254 Quality Systems jobs in South Africa
Manager Quality Systems
Posted 19 days ago
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Job Description
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.
Manager quality systems
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Quality systems manager
Posted today
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Sr Director, Quality Systems
Posted 13 days ago
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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
#J-18808-LjbffrSr director, quality systems
Posted today
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Manager Quality Systems South Africa,Somerset West
Posted 19 days ago
Job Viewed
Job Description
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.
Manager quality systems south africa,somerset west
Posted today
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Job Description
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Quality Management
Posted 4 days ago
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Job Description
Are you an experienced Quality Management professional ready to take your career to the next level on a high-profile petrochemical project?
An exciting opportunity has become available for a skilled and driven Quality Management Specialist to support a major client in the energy sector. This role offers the chance to work on large-scale projects where your expertise will make a significant impact across welding fabrication and compliance processes.
The successful candidate will be responsible for verification and validation across multiple quality disciplines, including auditing contractor quality systems, ensuring fabrication standards, reviewing technical documentation, and leading quality-focused audits. This role requires a proactive and assertive professional who thrives in high-pressure shutdown or project environments.
Key responsibilities include:
- Verifying contractor QMS, QC trackers, and quality control documentation
- Conducting vendor validation audits and site surveillance
- Reviewing welding procedures, NDE reports, PMI requirements, and coating/insulation specs
- Managing QC data books and sign-off on QC packs
- Auditing and ensuring adherence to ASME, ISO, API, PER, and SANS standards
- Tracking and closing out exception items, punch lists, and audit findings
The ideal candidate will bring:
- 10 years of experience in petrochemical welding and fabrication
- Strong knowledge of AE standards and procedures
- ISO Auditor certification
- Quality Project Management experience
- Proven ability to lead quality matters with confidence and maturity
- Proficiency in MS Word, Excel, Outlook, and industry-specific applications
- Understanding of P&ID, Isometric drawings, and refinery processes
EE Disclaimer:
All positions will be filled in accordance with the company's Employment Equity plan. We encourage people with disabilities to apply.
Application Unsuccessful Disclaimer:
If you do not receive feedback within two weeks of your application, please consider it unsuccessful. Keep an eye on our website and other career sites for future opportunities.
Key Skills:
Attorney At Law, Customer, Customer Support, Excel, Assembling
Employment Type: Full-Time
Experience: 10+ years
Vacancy: 1
#J-18808-LjbffrQUALITY MANAGEMENT OFFICER
Posted 13 days ago
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Job Description
Job title: Quality Management Officer
Job Location: Gauteng, Johannesburg
Deadline: August 18, 2025
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Minimum Requirements
- National Diploma / Degree in Quality Management, TQM, Operations, or equivalent
- Knowledge of ISO 9001:2015 Quality Management Standards
- Certificate in ISO 9001:2015 Quality Management Systems Auditing based on ISO 19011 and ISO 17021
- Two years practical experience in implementing & maintaining a Quality Management System
- Knowledge of SHE Management System will be an advantage
- Computer literate
- Code 8 driver’s licence
Primary Duties
- Implement & maintain Quality Management System as guided by ISO 9001:2015 standard
- Conduct audits at site level
- Conduct awareness sessions on Quality Management System
- Motivate site management and staff support for Quality Management
- Identify, report, and take action on deviations from set standards to achieve continual improvement
- Integrate the Quality Management System with the Safety, Health, and Environment Management System
- Measure QMS performance
- Oversee production / manufacturing jobs
Quality management officer
Posted today
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