205 Quality Systems jobs in South Africa

The Manager Quality Systems will be responsible for developing the Quality policies, processes, standards, and systems for the Company. The incumbent will also be responsible for developing and sustaining the Quality Management System in line with ISO 9001 and industry quality requirements across the organization through existing and new procedures. Conduct audits and manage the audit program to ensure compliance and that all nonconformities raised during audits are effectively corrected and independently verified. Embed a culture of continuous improvement throughout the company.

KEY PERFORMANCE AREAS:

• Perform internal and external quality audits and compile detailed reports of findings.
• Be involved in the establishment of quality policies and procedures.
• Ensure that the Quality Management System (QMS) is regularly reviewed and updated to meet the requirements of external certification bodies.
• Ensure that all necessary systems and procedures are in place to meet customer requirements and audits.
• Conduct internal, external, and third-party audits, compile corrective action plans, and follow up on completion.
• Manage and investigate non-conformances & ensure corrective action/recommendations are coordinated and implemented in consultation with stakeholders.
• Compile monthly reports and reports of audits.
• Manage and monitor quality indicators such as quality failure costs, customer complaints, and NCRs.
• Review production QC requirements and ensure that QC documentation meets the requirements of the Quality system.
• Identify improvement opportunities and implement them in consultation with stakeholders.
• Be the Point of Contact (POC) with Certification Bodies and arrange audits.
• Manage the audit non-conformity database and provide detailed analysis of non-conformities.
• Coach and lead the Quality team to ensure RDM meets Quality objectives and delivers best practice results, added value, and continuous improvements.
• Manage and coordinate standardization of quality management systems across all sites.

WHAT QUALIFICATIONS YOU SHOULD HAVE:

• BEng / BTech in Quality or equivalent.
• ISO 9001 implementation.
• Six Sigma / Lean Manufacturing skills (advantageous).
• At least 5 years' relevant experience in quality management within a medium to large organization, of which 3 years should have been in a managing employees, performance management, and leadership role.
• The ability to interface, liaise, and communicate with various internal and external stakeholders.
• Good planning, integration, and resources management skills.
• Excellent written and verbal communication skills including meeting facilitation and presentation.
• Interpersonal skills and ability to effectively collaborate with multiple disciplines both internally and externally.
• Clear Security Screening record.
• Medical fit to work in a specific environment.
• Code 8 Drivers Licence.
• Ability to work independently and in cross-functional teams.
• Excellent organisational skills.
• Planning, organising, and decision making.

WHAT WE OFFER YOU:

• Market-related salary.
• 13th Cheque.
• Medical Aid.
• Pension Fund.
• Incentive Bonus.
• Bursary Schemes.

Job Summary

Responsible for providing compliance leadership in External Audits, CAPA, Complaints, Medical Device and Vigilance Reporting, Quality Systems Management. Ensures ongoing compliance with all applicable regulations and standards through the management, continuous review, and ongoing effectiveness of these systems. Develops and coordinates plans to identify, address, and mitigate potential risks to compliance in various processes implemented to support the Company's activities. Develops and mentors the quality compliance team, ensuring their competence, focus and productivity in relation to their specific job functions. Interfaces with individuals at all levels of the organization including other Masimo's facilities.

Duties & Responsibilities

• Maintain, support, and ensure effective implementation of the following quality systems: CAPA, Complaint Management, MDR and Vigilance Reporting, and Quality Systems Management.


• Ensure all areas of direct responsibility are compliant with the Company's Quality Manual, which includes but is not limited to the following regulations and standards: FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806, ISO 13485, Canadian Medical Device Regulation (SOR 98-282), Japan's Pharmaceutical and Medical Devices Act (PMDA), Brazil GMP, Therapeutic Goods Regulation (Australia), EU MDR (2017/745) and Medical Device Directive (93/42/EEC) (European) requirements.


• Responsible for project management activities, including leading specific projects focused on improvements in CAPA, Complaints, MDR and Vigilance Reporting, metrics reviews and the establishment of appropriate metrics, and Management Review.


• Responsible for preparing, maintaining, and updating procedures related to the quality compliance department. Serve as the Deputy Management Representative.


• Responsible for communicating (e.g., verbal and written) with regulatory agencies and customers.


• Ensure Management Representative and senior management personnel are adequately informed of the current performance of the quality system and any need for improvements.


• Provide Engineering and Quality with feedback from quality metric trend reviews and the output of analysis of data activities.


• Oversee administrative activities related to the management of the quality compliance team.


• Assist with coordination, hosting and ensuring proper follow up to external audits (e.g., FDA Inspections, Customer Audits, and ISO audits).


• Direct, plan, delegate and manage department budget and staff including hire, promote, demote, reclassify or terminate employees, write and conduct performance appraisals and disciplinary actions plans, make salary decisions (pay increases or new hire offers), create training and employee development plans, and handle department employee relations issues.


• Perform other duties and projects as assigned.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 10 years of experience in Quality Assurance/Compliance in a medical device environment.


• At least 7 years of experience in managing direct reports at the manager level.


• Experienced in FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806; ISO 13485, SOR 98-282 CMDR (Canadian Medical Device Regulation), PMDA (Japanese), Resolution RDC #59 (Brazil), TGA (Australia), EU MDR and MDD (European) requirements.


• Excellent communication skills both verbal and written and the ability to interface effectively with personnel at all levels of the organization, with regulatory agencies and customers.


• Experience utilizing project management practices and methodologies.


• Well-organized and accustomed to maintaining excellent records.


• Leadership and Managerial skills.


• A "hands-on" individual who is capable and dedicated to getting the job done with minimal support and direction.


• Ability to travel ~25%/year.

Preferred Qualifications

Experienced in the management of quality and quality compliance related quality professionals.

Education

Bachelor's Degree in Science, Engineering, or Management required.

Compensation

The anticipated salary range for this position is $195,000 - $260,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 25% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is an Equal Opportunity employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

***NO AGENCIES PLEASE*** Thank you!

#LI-Onsite

The Manager Quality Systems will be responsible for developing the Quality policies, processes, standards, and systems for the Company. The incumbent will also be responsible for developing and sustaining the Quality Management System in line with the ISO 9001 and industry quality requirements across the organisation through existing and new procedures. Conduct audits and manage the audit program to ensure compliance and that all nonconformities raised during audits are effectively corrected and independently verified. Embed a culture of continuous improvement throughout the company.

KEY PERFORMANCE AREAS:

• Perform internal and external quality audits and compile detailed reports of findings.
• Be involved in the establishment of quality policies and procedures.
• Ensure that the Quality Management System (QMS) is regularly reviewed and updated to meet the requirements of external certification bodies.
• Ensure that all necessary systems and procedures are in place to meet customer requirements and audits.
• Conduct internal, external, and third-party audits, compile corrective action plans, and follow up on completion.
• Manage and investigate non-conformances & ensure corrective action/recommendations are coordinated and implemented in consultation with stakeholders.
• Compile monthly reports and reports of audits.
• Manage and monitor quality indicators such as quality failure costs, customer complaints, and NCRs.
• Review production QC requirements and ensure that QC documentation meets requirements of the Quality system.
• Identify improvement opportunities and implement them in consultation with stakeholders.
• Be the Point of Contact (POC) with Certification Bodies and arrange audits.
• Manage the audit non-conformity database and provide detailed analysis of non-conformities.
• Coach and lead the Quality team to ensure RDM meets Quality objectives and delivers best practice results, added value, and continuous improvements.
• Manage and coordinate standardisation of quality management systems across all sites.

WHAT QUALIFICATIONS YOU SHOULD HAVE:

• BEng / BTech in Quality or equivalent.
• ISO 9001 implementation.
• Six Sigma / Lean Manufacturing skills (advantageous).
• At least 5 years' relevant experience in quality management within a medium to large organization, of which 3 years should have been in managing employees, performance management, and leadership roles.
• The ability to interface, liaise, and communicate with various internal and external stakeholders.
• Good planning, integration, and resources management skills.
• Excellent written and verbal communication skills including meeting facilitation and presentation.
• Interpersonal skills and ability to effectively collaborate with multiple disciplines both internally and externally.
• Clear Security Screening record.
• Medical fit to work in a specific environment.
• Code 8 Drivers Licence.
• Ability to work independently and in cross-functional teams.
• Excellent organisational skills.
• Planning, organising, and decision making.

WHAT WE OFFER YOU:

• Market-related salary.
• 13th Cheque.
• Medical Aid.
• Pension Fund.
• Incentive Bonus.
• Bursary Schemes.

Domain Hyg Saf Sec Societal Env Qual

Type of contract: Regular position

Experience: Minimum 3 years

• Risks: Safety, environment, hygiene
• Culture: Moderate culture of Quality and Safety requirements
• Legal: Culture of self-regulation on legislation and compliance

• Manage and ensure standardization of Health, Safety, Environmental and Quality systems for TMSA, ensuring compliance with all relevant HSSE company norms, policies, and procedures to minimize risk and liability.
• Implement and maintain HSE management systems.
• Manage and maintain the HSE digital roadmap.
• Ensure compliance with the procure to pay process.
• Key Performance Areas: Quality, Safety, and Environmental management system compliance, System utilization.

The HSSE Systems & Quality Practitioner would carry out the following skills and experience:

• Management and Improvement of HSSE System.
• Contribute to the maintenance and continuous improvement of the affiliate’s One Maestro and Integrated ISO (45001, 14001) management system.
• Continuous update of all One Maestro and ISO related requirements and their applicability to TMSA and its subsidiaries/branches.
• Ensure adherence to the company’s HSSE standards, local by-laws, and government legislation.
• Support the HSSE Systems and Quality Specialist in communicating HSSE Return on Experience (REX) and coordination of the Committee on Return on Experience (COREX).
• Facilitate all HSSE Communication Programs and Initiatives such as Safety Golden Rules and KPIs.
• Provide support to other HSSE Disciplines regarding various initiatives and projects.
• Carry out lawful and reasonable instructions from the HSSE Systems and Quality Specialist, ELHS manager, and GM: HSSE.
• Escalate identified high-risk conditions and follow up on required actions.
• Oversee the Procure to pay process, budgets, and provision movements for the division.
• Support the Systems and Quality Specialist in implementing Office 365 tools and apps for system improvement.
• Act as the Compliance officer for the Division.
• Monitor and evaluate HSSE system gaps and performance from quarterly evaluations and audits.
• Support the Systems and Quality Specialists in assessing local regulation at the corporate level.
• Manage and minimize HSE risk by ensuring compliance with all HSE Policies, rules, guidelines, and legal requirements.
• Promote a safe working environment and contribute to the company HSE KPIs and risk reduction strategies.

• Ensure that business management systems satisfy the requirements of the Group preferred HSSE Management System.
• Schedule HSSE internal and external audits (management systems and legal compliance).
• Follow through on all corporate internal and external HSSE audit findings.
• Manage non-conformances and corrective actions regarding HSSE audits and assessments.
• Conduct trend analysis on HSSE system non-compliances and implement corrective actions.
• Support the Systems and Quality Specialist in managing HSSE electronic management systems.
• Develop, review, and maintain HSSE policies, procedures, templates, and protocols in line with ISO 9001 requirements.
• Manage all HSSE-related documents in terms of document control.
• Ensure HSSE practitioners/managers at operation sites have access to the latest HSSE management system documents.
• Coordinate various HSSE reporting programs.

• Advise and train within the area of responsibility on the development, execution, and effectiveness of the HSE Management systems.
• Train, mentor, and coach HSSE Practitioners based on sites.
• Develop and present awareness training on HSE issues when required.

TotalEnergies values diversity, promotes individual growth, and offers equal opportunity careers.

TotalEnergies is an equal opportunity employer and all applicants that meet the specified criteria will receive consideration for employment without discrimination on any arbitrary ground.

Domain Hyg Saf Sec Societal Env Qual

Type of contract: Regular position

Experience: Minimum 3 years

• Risks: Safety, environment, hygiene
• Culture: Moderate culture of Quality and Safety requirements
• Legal: Culture of self-regulation on legislation and compliance

• Manage and ensure standardization of Health, Safety, Environmental and Quality systems for TMSA, ensuring compliance with all relevant HSSE company norms, policies, and procedures to minimize risk and liability.
• Implement and maintain HSE management systems.
• Manage and maintain the HSE digital roadmap.
• Ensure compliance with the procure to pay process.
• Key Performance Areas: Quality, Safety, and Environmental management system compliance, System utilization.

The HSSE Systems & Quality Practitioner would carry out the following skills and experience:

• Management and Improvement of HSSE System.
• Contribute to the maintenance and continuous improvement of the affiliate’s One Maestro and Integrated ISO (45001, 14001) management system.
• Continuous update of all One Maestro and ISO related requirements and their applicability to TMSA and its subsidiaries/branches.
• Ensure adherence to the company’s HSSE standards, local by-laws, and government legislation.
• Support the HSSE Systems and Quality Specialist in communicating HSSE Return on Experience (REX) and coordination of the Committee on Return on Experience (COREX).
• Facilitate all HSSE Communication Programs and Initiatives such as Safety Golden Rules and KPIs.
• Provide support to other HSSE Disciplines regarding various initiatives and projects.
• Carry out lawful and reasonable instructions from the HSSE Systems and Quality Specialist, ELHS manager, and GM: HSSE.
• Escalate identified high-risk conditions and follow up on required actions.
• Oversee the Procure to pay process, budgets, and provision movements for the division.
• Support the Systems and Quality Specialist in implementing Office 365 tools and apps for system improvement.
• Act as the Compliance officer for the Division.
• Monitor and evaluate HSSE system gaps and performance from quarterly evaluations and audits.
• Support the Systems and Quality Specialists in assessing local regulation at the corporate level.
• Manage and minimize HSE risk by ensuring compliance with all HSE Policies, rules, guidelines, and legal requirements.
• Promote a safe working environment and contribute to the company HSE KPIs and risk reduction strategies.

• Ensure that business management systems satisfy the requirements of the Group preferred HSSE Management System.
• Schedule HSSE internal and external audits (management systems and legal compliance).
• Follow through on all corporate internal and external HSSE audit findings.
• Manage non-conformances and corrective actions regarding HSSE audits and assessments.
• Conduct trend analysis on HSSE system non-compliances and implement corrective actions.
• Support the Systems and Quality Specialist in managing HSSE electronic management systems.
• Develop, review, and maintain HSSE policies, procedures, templates, and protocols in line with ISO 9001 requirements.
• Manage all HSSE-related documents in terms of document control.
• Ensure HSSE practitioners/managers at operation sites have access to the latest HSSE management system documents.
• Coordinate various HSSE reporting programs.

• Advise and train within the area of responsibility on the development, execution, and effectiveness of the HSE Management systems.
• Train, mentor, and coach HSSE Practitioners based on sites.
• Develop and present awareness training on HSE issues when required.

TotalEnergies values diversity, promotes individual growth, and offers equal opportunity careers.

TotalEnergies is an equal opportunity employer and all applicants that meet the specified criteria will receive consideration for employment without discrimination on any arbitrary ground.

• Keeping customer data squeaky clean, compliant, and ready for inspection
• Owning the quality of KYC and AML records like your professional rep depends on it (spoiler: it kinda does)
• Working cross-functionally to improve data processes while secretly judging poor naming conventions
• Ensuring FICA and FATCA compliance isnt just tick-boxedits embedded
• Making data make sense, no matter how messy it arrives to you

• Solid experience with KYC, AML, FICA, and FATCA (buzzwords, but you actually know what they mean)
• A detectives mindset with a perfectionists eye
• Data governance know-how and a love for accuracy
• Bonus: You've worked with financial institutions and lived to tell the tale

• Be the person who keeps the business compliant and confident
• Work in a team that respects data as much as you do
• Have real impact, less red tape, and a lot of ownership
• Oh, and your Excel sheets might finally get the respect they deserve

A wheelchair manufacturer in Roodepoort requires a Quality Control Officer with a sound technical background as well as initiative, drive and the ability to work under pressure and multi-task.

1. Oversee receiving of faulty products, fault finding and return of repaired or replacement products to other branches.
2. Communicate and record faults with the sales team.
3. Inspect the products on a daily basis to ensure compliance and record keeping.
4. Ensure that daily quality checks are done per department.
5. Assist with the creation and implementation of quality inspection procedures and work instruction documents.
6. Ensure that the QMS document processes and information are up to date.
7. Ensure all customer complaints are addressed and recorded.
8. Ensure that all change requests are documented and maintained.
9. Monitor, review, update and implement changes to management systems requirements.

1. Sound technical ability and experience.
2. Minimum of a Diploma in Industrial Engineering or similar.
3. Experience and knowledge in maintaining the ISO 9001 or ISO 13485.
4. Experience in document control and record keeping.
5. Experience in drafting, implementing and controlling SOPs, WIs and QC checks.

CTC R15000 to R20 000 per month.

1x Quality Management Specialist (Re-advertisement)

Ref No: 6938

Business Unit: General

Reporting To: Chief Executive Officer

CTC (Basic Salary): R 1 072,969.03 – R 1 306,719.47 Negotiable

Purpose

Purpose: To implement and monitor adherence to and effectiveness of quality management systems across the NRCS.

• Implementation and Maintenance of Quality Management System (QMS)
• Conducting Quality Audits
• Handling of Internal and External Customer Complaints
• Quality Management Documentation
• Stakeholder Management
• Budget Management
• Corporate Governance & Risk Management

Qualification / Experience

- National Diploma (NQF Level 6) in Quality Management

- SAQI Certificate in Quality Control or Quality Assurance would be advantageous

- 5 years’ experience in quality management

Knowledge

- Sound knowledge of regulatory requirements/standards

- Sound knowledge of ISO 9000 standards

- Knowledge of financial principles

- Communication skills

- Problem-solving skills

- Planning and organizing skills

- Risk management skills

- Facilitation skills

Behavioral Attributes

Special Note

NB: Preferred candidate is African Male/Female & People with Disability to meet NRCS EE targets

• Suitable candidates will be subjected to employment and criminal verification checks
• Suitable candidates will undergo competency assessment
• Please submit application to:
• Applications must be submitted on a signed AS 83 form and accompanied by a comprehensive Curriculum Vitae and copies of qualifications and ID
• Correspondence will be limited to shortlisted candidates
• People with disabilities are encouraged to apply
• Late submissions will be disqualified
• Applicants are responsible for SAQA evaluation of foreign qualifications
• Closing date for applications: 18 August 2022

1x Quality Management Specialist (Re-advertisement)

Ref No: 6938

Business Unit: General

Reporting To: Chief Executive Officer

CTC (Basic Salary): R 1 072,969.03 – R 1 306,719.47 Negotiable

Purpose

Purpose: To implement and monitor adherence to and effectiveness of quality management systems across the NRCS.

• Implementation and Maintenance of Quality Management System (QMS)
• Conducting Quality Audits
• Handling of Internal and External Customer Complaints
• Quality Management Documentation
• Stakeholder Management
• Budget Management
• Corporate Governance & Risk Management

Qualification / Experience

- National Diploma (NQF Level 6) in Quality Management

- SAQI Certificate in Quality Control or Quality Assurance would be advantageous

- 5 years’ experience in quality management

Knowledge

- Sound knowledge of regulatory requirements/standards

- Sound knowledge of ISO 9000 standards

- Knowledge of financial principles

- Communication skills

- Problem-solving skills

- Planning and organizing skills

- Risk management skills

- Facilitation skills

Behavioral Attributes

Special Note

NB: Preferred candidate is African Male/Female & People with Disability to meet NRCS EE targets

• Suitable candidates will be subjected to employment and criminal verification checks
• Suitable candidates will undergo competency assessment
• Please submit application to:
• Applications must be submitted on a signed AS 83 form and accompanied by a comprehensive Curriculum Vitae and copies of qualifications and ID
• Correspondence will be limited to shortlisted candidates
• People with disabilities are encouraged to apply
• Late submissions will be disqualified
• Applicants are responsible for SAQA evaluation of foreign qualifications
• Closing date for applications: 18 August 2022