Quality Engineer; Development/NPI
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-07-01
Listing for:
Beacon Hill
Full Time
position Listed on 2026-07-01
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
We’re partnering with a growing medical device manufacturing team looking to add a Quality Engineer to support new product development (NPI) efforts. This is a hands‑on role working closely with engineering and operations to bring new products from development through validation and into production.
This is a great opportunity for someone early in their career who is looking to build out their skillset in a fast‑paced, supportive environment – the hiring manager is very hands‑on and open to coaching the right person.
What You’ll Be Doing- Support new product introduction (NPI) activities, partnering closely with engineering and manufacturing teams
- Assist with and/or author validation documentation (IQ/OQ/PQ, validation plans, test method validation, control plans, PFMEAs)
- Participate in root cause investigations (nonconformances, CAPAs, process issues) using structured problem‑solving tools
- Perform data analysis and process capability studies (Minitab, basic statistics) to support development and manufacturing decisions
- Help develop and qualify inspection methods, sampling plans, and measurement systems
- Collaborate cross‑functionally across Quality, R&D, and Operations to support multiple development projects at once
- 2–4+ years of experience in Quality Engineering, Design Assurance, or similar (medical device preferred)
- Exposure to validation activities (IQ/OQ/PQ) and ability to speak to your approach or thought process
- Experience with root cause analysis, CAPA, FMEA/PFMEA, or nonconformance investigations
- Familiarity with ISO 13485, GMP, or FDA‑regulated environments
- Strong attention to detail and ability to work in a fast‑paced, multi‑project environment
- Highly coachable, eager to learn
, and comfortable picking up new concepts quickly
- Experience in automated manufacturing environments
- Exposure to GD&T, blueprint reading, or CAD
- Familiarity with Minitab or statistical tools
- Growing team with strong leadership and a collaborative culture
- Opportunity to gain hands‑on exposure to NPI and validation work early in your career
- Clear path for growth and advancement
- Supportive environment with flexibility despite an onsite schedule
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