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Quality Engineer
Philips - Phoenix, AZ
posted 2 months ago
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. Your responsibilities will include managing product non-conformances, supporting the evaluation and approval of Device History Records, monitoring environmental conditions in the warehouse, and implementing effective Corrective and Preventive Actions (CAPA). This position may also involve supervisory responsibilities for the Site Level Quality Assurance Team.
Responsibilities
- Manage product non-conformances per site work instructions.
- Follow up, approve, and dispose of Nonconformance Products (NCP) using the Philips nonconformance quality system tool.
- Support the Operation Manager in evaluating and approving Device History Records (DHR).
- Monitor warehouse environmental conditions to ensure compliance with storage specifications.
- Act as a CAPA owner, implementing effective Corrective and Preventive Actions.
- Supervise the Site Level Quality Assurance Team, if applicable.
Requirements
- Bachelor's degree in engineering or science or equivalent experience in the medical device industry.
- 3+ years of related experience in the medical device industry.
- Working knowledge of global regulations and standards such as ISO13485 and FDA 20CFR820.
Benefits
- Generous PTO
- 401k with up to 7% match
- Health Savings Account (HSA) with company contribution
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus
