Quality Engineer, International Programs - Health
Santa Clara Valley (Cupertino), California, United States
Operations and Supply Chain
The Health Special Projects group is looking for a Quality Engineering Associate to lead international expansion efforts for new product and sustaining efforts for health technology related projects.
- 5+ years of medical device experience in a quality/compliance role
- Familiarity with 21 CFR 820, ISO-13485, and other applicable regulations
- Experience implementing quality system/product requirements for regions outside the US such as Japan, Brazil, Australia, Europe, Canada, China
- Experience interpreting requirements and writing procedures
- Strong organizational and management skills
- Excellent communication skills, both verbal and written
The candidate will be focused on: - Identifying and interpreting applicable regional regulations and requirements for health tech projects - Assessing impact of regional requirements and implementing quality plans to ensure systems/products align with regional requirements - Communicating requirements to multi-functional team members in clear concise manner - Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues - Enforcing strict project schedules - Participating in new product and sustaining 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. - Staying in sync 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, multi-functional interpersonal skills and experience are critical to success in this role. This person will interact with all engineering design disciplines and project management teams. You will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to multi-functional teams.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
- - Experience in working on regulated medical devices (specifically) 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.