Senior Manufacturing Quality Engineer – NPI/Validation
Job in
Fall River, Bristol County, Massachusetts, 02720, USA
Listed on 2026-06-04
Listing for:
RBW Consulting LLP
Full Time
position Listed on 2026-06-04
Job specializations:
-
Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Validation Engineer -
Engineering
Quality Engineering, Manufacturing Engineer, Validation Engineer, Process Engineer
Job Description & How to Apply Below
Position Overview
Our client is an advanced medical device Contract Manufacturer seeking a Senior Manufacturing Quality Engineer to support the buildout, validation, and production readiness of its metal additive manufacturing systems. This role will take a lead position in manufacturing quality, equipment qualification, process validation, and manufacturing scale‑up, supporting the deployment of next‑generation 3D printing manufacturing systems. The ideal candidate will bring deep experience in manufacturing quality and validation and be capable of driving complex initiatives in a fast‑paced, high‑growth environment.
Key Responsibilities- Lead Installation Qualification (IQ) activities for new 3D printing systems
- Lead and drive equipment and process validation efforts (IQ/OQ/PQ)
- Own and support new product qualification and NPI process validation
- Interpret and analyze dimensional inspection and metrology data
- Lead or guide Gage R&R (measurement system analysis) activities
- Partner cross‑functionally with Manufacturing, Quality, and Engineering teams
- Support development of inspection strategies (CMM, QC integration)
- Drive root cause investigations and resolution of manufacturing issues
- Ensure compliance with medical device quality and regulatory standards
- Medical Device Manufacturing Quality Engineering: 8–10+ years’ experience
- Strong experience leading equipment and process validation (IQ/OQ/PQ)
- Experience with capital manufacturing equipment qualification
- Experience supporting NPI and process validation efforts
- Experience in manufacturing scale‑up / production readiness environments
- Strong background in metrology, QC inspection, and Gage R&R
- Ability to lead initiatives and influence cross‑functional teams
- Strong technical troubleshooting and problem‑solving skills
- Experience supporting new facility buildouts or production line deployment
- Experience with additive manufacturing / 3D printing
- Exposure to complex manufacturing systems or capital equipment
- Familiarity with CMM and metrology workflows
- Experience in high‑growth manufacturing environments
Position Requirements
10+ Years
work experience
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