Senior Design Quality Engineer - Health
Santa Clara Valley (Cupertino), California, United States
Operations and Supply Chain
The Health Special Projects group is looking for a Quality Associate (QAs) to lead development and sustaining efforts for health technology related projects.
- 10+ years of medical device experience in a quality/compliance role
- Familiarity with 21 CFR 820, ISO-13485, and other applicable regulations
- Experience interpreting requirements and writing procedures
- Strong organizational and management skills
- Excellent communication skills, both verbal and written
Quality Engineers are responsible for : - Ensuring that Design Controls are properly executed in accordance to established standard operating procedures - Leading risk management activities in relation to new product development projects - Identifying and implementing effective systems to support products post market - Leading the execution of systems which identify and resolve quality issues (CAPAs) - Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues - Leading and implementing various product and process improvement methodologies - Leading the investigation, resolution and prevention of product and process nonconformances - Participating in new product development teams (represent the Quality function as a Core Team Member) - Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. - Complying with applicable regulatory requirements, procedures, and processes, requirements The candidate 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 social skills and experience are essential to success in this role. This person will interact with all engineering design disciplines and project management teams. You will be responsible for managing communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
- - Certified Lead Audit for ISO-13485, 21 CFR 820, etc.
- - Experience in working on software products within a quality or regulatory system
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.