Principal Supplier Quality Engineer

5 hours ago

Redwood City, California, United States Element Science Inc Full time
Job Summary:

Element Science Inc. is seeking a highly skilled Principal Supplier Quality Engineer to join our team. As a key member of our product development and operations team, you will be responsible for identifying, qualifying, and cultivating suppliers in line with ISO 13485 requirements. Your expertise in quality management and regulatory compliance will ensure that our medical devices meet the highest standards of quality and safety.

Key Responsibilities:

Manage control of external suppliers and contract manufacturers to ensure the supply of quality materials
Develop procedures and best practices for supplier management
Act as the quality representative in external supplier communications
Lead supplier qualification program and maintain an up-to-date Approved Supplier List
Generate supplier-related metrics and execute data-driven improvements
Communicate supplier-related issues to responsible supplier representatives and facilitate the resolution of supplier issues through quality process e.g., SCAR
Support improvement of supplier processes through audits and feedback to suppliers
Collaborate with suppliers on the creation and maintenance of quality tools such as FMEAs, control plans
Support improvement of Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure
Mentor junior engineers

Requirements:

10+ years of relevant experience in a Medical Device environment
Bachelor's Degree in Science or Engineering, Master's degree is a plus
Experience with electronics manufacturing, injection molding preferred
Working knowledge of current ISO 13485 standard, QSR, and ISO 14971
Ability to work in a team environment, manage multi-tasking, and be disciplined in completing tasks on schedule
Excellent written and verbal communication skills

Benefits:

Element Science Inc. offers a very competitive salary and benefits package including, but not limited to:
Stock Options
90% employer-paid medical, dental, and vision insurance
Company-paid Basic Life Insurance
401(k) retirement plan (Traditional and Roth)
Competitive Paid Time Off
Paid Holidays
FSA (Flexible Spending Accounts)
HSA (Health Savings Account)
Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

Element Science Inc. is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

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