QMS Specialist

QMS Specialist



Location: Cupertino, CA


ABOUT THIS FEATURED OPPORTUNITY


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 group is looking for a contractor QMS Specialist- Medical Devices to support regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.



THE OPPORTUNITY FOR YOU


The contractor QMS Specialist will be responsible for developing, implementing, and supporting a quality management system to support new regulated device features.

• QMS Implementation and maintenance: lead the development, implementation, and monitoring of a compliant QMS to support new products in accordance with applicable standards, e.g. ISO 13485, 21 CFR 820
• Audit preparation: ensure internal readiness for internal and external audits, including gap assessments, preparing project teams and external partners (where applicable). Managing post-audit activities
• Supplier management: qualify and develop OUS entities such as Authorized Representatives and importers to support international access. Review and maintain quality agreements with OUS partners to ensure clear responsible and compliance with local market requirements. Evaluate, qualify, and onboard suppliers; maintain supplier files.

KEY SUCCESS FACTORS

• 5 years of experience in Quality Management Systems supporting Medical Devices.

• Experience working for a Medical Device start up, small company or being a consultant where the procedures aren't already created for you
• Knowledge of medical device regulatory requirements (e.g. ISO 13485, MDSAP requirements, EU MDR, etc...)

NICE TO HAVES

• Both US and outside of US global regulations experience
• Seeking someone who can work independently and doesn't need their hand held
• Experience supporting Class 1 and Class 2 hardware medical devices

About INSPYR Solutions


Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.


INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.


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