Quaity Engineer
Join a Growing Medical Device Company
We're looking for a hands-on Manufacturing Quality Engineer to play a key role in supporting manufacturing operations, driving quality improvements, and ensuring products meet the highest standards of compliance and performance.
This is an excellent opportunity for someone who enjoys solving problems on the manufacturing floor, working cross-functionally, and making a visible impact in a growing business.
Key Responsibilities
- Lead quality activities within cleanroom manufacturing operations.
- Drive CAPA, NCR and root cause investigations.
- Support supplier audits and supplier quality improvements.
- Review and approve incoming materials and quality documentation.
- Partner with Design Engineering on manufacturability and design transfer projects.
- Support process validation and annual requalification activities.
- Identify and implement manufacturing quality improvements.
- Support initiatives to bring outsourced manufacturing activities in-house.
What We're Looking For
- 3-7 years of Quality Engineering experience.
- Medical device manufacturing experience is essential.
- Strong knowledge of ISO 13485.
- Experience with supplier quality and auditing.
- Experience with CAPA, NCRs and root cause investigations.
- Process validation experience (IQ/OQ/PQ).
- Comfortable working independently and taking ownership.
- A practical, hands-on engineer with a continuous improvement mindset.
FAQs
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