We've partnered with a rapidly growing medical device manufacturing organization looking to hire multiple Quality Engineering positions in support of a large scale-up initiative at an exciting time in their growth as they expand their manufacturing capabilities. These are pivotal roles focused on driving new revenue, opening new accounts, and building long-term client partnerships.
If you thrive in fast-paced production environments, enjoy solving manufacturing quality and validation challenges, and want to support a high-growth medical device organization during a critical scale-up phase, this opportunity is for you!
Quality Engineer Role Summary
You’ll be responsible for supporting manufacturing quality, validation, and production readiness activities as the organization expands its manufacturing capabilities.
- Support day-to-day Manufacturing Quality Engineering activities on the production floor
- Partner with Manufacturing, Quality, Engineering, Operations, and R&D teams to resolve production quality issues
- Support manufacturing scale-up, production ramp, and new product/process introduction activities
- Lead or support investigations related to NCRs/NCMRs, deviations, CAPA, root cause analysis, and corrective actions
- Support process validation, equipment validation, inspection readiness, and documentation activities including IQ/OQ/PQ
- Review and analyze quality data, inspection results, and manufacturing trends to identify issues and drive improvements
- Support risk management activities including FMEA, process controls, and quality planning
- Help ensure products, processes, and documentation meet internal quality, regulatory, and customer requirements
Quality Engineer profile
- Quality Engineering experience within medical device, advanced manufacturing, or another regulated manufacturing environment
- Experience with process validation, equipment validation, IQ/OQ/PQ, inspection methods, and validation documentation
- Strong hands-on experience supporting production quality, manufacturing investigations, NCR/NCMR, CAPA, deviations, and root cause analysis
- Comfortable working cross-functionally with Manufacturing, Engineering, Quality, Operations, and R&D teams in a fast-paced production environment
Preferred Experience
- Medical device manufacturing quality experience
- Knowledge of GD&T, Gage R&R, metrology, inspection strategy, FMEA, SPC, or process capability
- Experience supporting manufacturing scale-up, production ramp, NPI, or new equipment/process implementation
- Experience with automated manufacturing, advanced manufacturing, machining, or complex mechanical products
Why this role?
- High-visibility role supporting a major manufacturing expansion initiative
- Opportunity to make a direct impact on production readiness, quality systems, and manufacturing performance
- Hands-on role with strong cross-functional exposure across Manufacturing, Engineering, Quality, and Operations
- Long-term growth potential with a rapidly scaling medical device manufacturing organization
Ideal for a hands-on Quality Engineer who enjoys solving production quality challenges, supporting validation and manufacturing readiness, and playing a key role in a fast-paced scale-up environment.