Description:
Responsibilities
- Work alongside manufacturing engineers and cross funtional engineering teams to identify gaps and implement corrective actions to achieve compliance.
- Execute equipment and process validation activities (IQ/OQ/PQ).
- Revise and maintain quality system records and technical documentation to ensure audit readiness.
- Liaise with supplier sand vendors on NPI and procurement of equipment and materials.
- work on NPI projects - validating new processes and new equipment being introduced to site.
- Lead and support the closure of CAPAs and NCRs with robust corrective actions.
- Develop clear, accurate technical documentation and SOPs for quality and manufacturing processes.
- Lean Mfg advantageous - process improvement projects.
- Collaborate with cross-functional teams, including Manufacturing, Quality, and Regulatory, to deliver sustainable solutions.
Skills & Experience Required
- Degree in Engineering, Quality, or a related discipline.
- 2+ years of experience in medical device/pharma manufacturing, quality engineering desirable.
- background in process and/or equipment validation (IQ/OQ/PQ) and CAPA resolution.
- project management experience desirable.
- Excellent technical writing and documentation abilities.
- Solid understanding of regulatory requirements. with GMP and/or med device industry
- Strong problem-solving mindset, with the ability to collaborate with engineering teams.