Production Quality Manager - Health
Job Description
Summary
Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices - strengthening our commitment to leave the world better than we found it.
The Health Special Projects group is looking for a Production Quality Manager to oversee quality engineering activities, and support Quality management system efforts for its medical device products.
The Health Special Projects group is looking for a Production Quality Manager to oversee quality engineering activities, and support Quality management system efforts for its medical device products.
Description
You will lead a team of quality engineers to ensure that products meet quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and risk management per ISO 14971. You will handle defining and implementing standard operating procedures to meet regulatory requirements while leading risk management activities in relation to design and production changes, and issues discovered during testing, and in the field. You will also focus on:
• Partnering with the post-market surveillance team and external partners to drive improvements for sustaining products
• Ensuring the execution of systems which identify and resolving quality issues (CAPAs)
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Ensuring the investigation, resolution and prevention of product and process non-conformance
• Providing support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
• Identifying quality improvement initiatives in support of QMS and other regulatory requirements.
• Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
The Quality Manager needs to be able to prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes.
Additionally, cross-functional communication skills and experience are crucial to success in this role. You will interact with all engineering design disciplines and project management teams, and will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.
• Partnering with the post-market surveillance team and external partners to drive improvements for sustaining products
• Ensuring the execution of systems which identify and resolving quality issues (CAPAs)
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Ensuring the investigation, resolution and prevention of product and process non-conformance
• Providing support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
• Identifying quality improvement initiatives in support of QMS and other regulatory requirements.
• Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
The Quality Manager needs to be able to prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes.
Additionally, cross-functional communication skills and experience are crucial to success in this role. You will interact with all engineering design disciplines and project management teams, and will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.
Minimum Qualifications
- B.S. ME/EE/BME/CS degree or equivalent in any engineering/ science discipline
- 10+ years of medical device experience in a quality/regulatory role
- Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
- Experience interpreting requirements and implementing standard operating procedures
- Experience with design control, production& process control, and risk management activities for medical devices, including development and maintenance of design history files
- Expertise in execution of design controls and production processes.
Preferred Qualifications
- Experience working on software and hardware products within a quality or regulatory system.
- Shown background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
- Proven competence in determination of appropriate global regulatory requirements for new products and product changes.
- Strong organizational and leadership skills.
- Excellent communication skills, both verbal and written.
Pay & Benefits
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