Quality Engineer (Development/NPI)

Quality Engineer (Development / NPI)

Onsite | Medical Device Manufacturing

6 Month Contract to Hire

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

• Medical device contract manufacturing (CMO) background

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