Production Quality Engineer - Medical Devices

Apple • Cupertino, CA

7d • Onsite

About The Position

We are looking for a cross-functional Quality team member, working closely with Engineering, Project management, and Post-Market surveillance teams. This role is critical in driving product and process issue resolution, implementing Quality improvements, performing risk assessments, and ensuring clear communication and timely progress reporting across teams. This person will 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, while defining and implementing standard operating procedures (SOPs). This is a site-based role.

Requirements

• B.S. ME/EE/BME/CS degree or equivalent in any Engineering/Science discipline
• 5+ 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 following standard operating procedures
• Experience with design control and risk management activities for Medical devices, including development and maintenance of design history files

Nice To Haves

• Experience working on software and hardware products within a Quality or regulatory system.
• Expertise in execution of design controls.
• Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
• Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
• Strong organizational and leadership skills.
• Excellent communication skills, both verbal and written.

Responsibilities

• driving product and process issue resolution
• implementing Quality improvements
• performing risk assessments
• ensuring clear communication and timely progress reporting across teams
• 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
• defining and implementing standard operating procedures (SOPs)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees