Quality Engineer (Development/NPI)

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 What They’re Looking For 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 Nice to Have Experience in automated manufacturing environments Exposure to GD&T, blueprint reading, or CAD Familiarity with Minitab or statistical tools Why This Role 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 #J-18808-Ljbffr Beacon Hill