Quaity Engineer
EPM Scientific · Upton, MA · 1 wk ago
On-siteManufacturingFull-time
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.