Philips QMS Manager 

South Africa, Free State, Dihlabeng Local Municipality 

223135159

QMS Manager

Your role:

• Reviews QMS and Engineering changes as well as Quality plans to ensurecompliance/conformanceto FDA regulations and other Regulatory Agency and consensus standard requirements
• Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
• Represents QMS/Engineering Change processes and records to regulatory agencies as required
• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule

You're the right fit if:

• Bachelor’s degree plus a minimum of 3+ years of related experience in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
• Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
• Experienced Engineer with proven success within teams and delivering on organizational objectives
• Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position In Cambridge is $93,000 to $127,000, Annually.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance to Cambridge MA