A leading Medical Device company are actively seeking a motivated candidate to fill their Senior Quality Engineer opportunity. This is an initial 12-month contract role with opportunity to extend/ convert to FTE. This is an onsite role is based out of Irvine, CA and the salary ranges between $53-58/hour depending on experience.
The Senior Quality Engineer will focus on providing ownership and support of all phases of the CAPA process including investigations, robust root cause analysis, development and implementation of corrective actions, and effectiveness monitoring and will interact with the global manufacturing sites.
- B.Sc. degree in engineering required.
- 5-7 years' experience required.
- Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the company systems/procedures.
- Quality Systems Engineering support, including Post-Market Quality Engineering support.
- Train, coach, and guide employees on CAPA procedures.