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Quality Engineer
$79,800 - $136,800/Yr
Koninklijke Philips N.V - Phoenix, AZ
posted 2 months ago
Full-time - Mid Level
Onsite - Phoenix, AZ
Ambulatory Health Care Services
About the position
As a Quality Engineer at Philips, you will play a crucial role in maintaining a robust Quality System to ensure compliance with national and international regulatory requirements for medical devices. This position involves managing product non-conformances, supporting the evaluation of product history records, and implementing corrective and preventive actions. You will also have potential supervisory responsibilities for the Site Level Quality Assurance Team.
Responsibilities
- Ensure that product non-conformances are managed per site work instructions.
- Responsible for the follow-up, approval, and disposition of Nonconformance Products (NCP).
- Manage the process on the Philips nonconformance quality system tool.
- Support the site Operation Manager during the evaluation and approval of product Device History Record (DHR).
- Monitor site warehouse environmental conditions to ensure products comply with storage specifications.
- As a CAPA owner, implement effective Corrective and Preventive Actions.
Requirements
- Bachelor's degree in engineering or science or equivalent experience in the medical device industry.
- 3+ years of related experience.
- Working knowledge of global regulations, requirements, and standards such as ISO13485 and FDA 20CFR820.
Benefits
- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
