What are the responsibilities and job description for the Quality Engineer position at Mount Kemble Search Group?
Manufacturing Line Quality Engineer
📍 Portsmouth, NH | Full-Time | Onsite
Are you a hands-on Quality professional who enjoys being on the manufacturing floor, solving problems in real time, and driving product quality in a regulated environment?
We are partnering with an innovative organization developing combination products that support patient self-care and improve healthcare outcomes. As the company continues to grow, they are seeking a Manufacturing Line Quality Engineer to provide day-to-day quality support for production operations and ensure products meet the highest standards of safety, compliance, and performance.
What You'll Do
- Provide quality engineering support directly on the manufacturing floor
- Perform and document line clearances, product changeovers, and production readiness activities
- Conduct incoming inspections of materials and components
- Perform in-process and final product testing
- Review batch records for accuracy, completeness, and GMP compliance
- Investigate nonconformances and support root cause analysis and CAPA activities
- Oversee material control, labeling verification, and product traceability requirements
- Support calibration programs for gauges, fixtures, and test equipment
- Partner with Manufacturing, Quality, and Operations teams on continuous improvement initiatives
- Support audits, validations, change controls, and other quality-focused projects
What We're Looking For
- Bachelor's degree in Engineering, Life Sciences, or related technical field preferred (equivalent experience considered)
- 2-4 years of experience in a regulated manufacturing environment
- Experience in medical device, pharmaceutical, combination product, or other highly regulated industries preferred
- Strong attention to detail and documentation skills
- Comfortable spending the majority of the day supporting production activities on the manufacturing floor
- Experience with inspections, testing, and quality investigations
- Familiarity with cGMP, FDA regulations, ISO standards, and quality systems
- Working knowledge of root cause analysis tools such as 5 Whys and Fishbone preferred
- Lean Manufacturing experience is a plus
Why This Opportunity?
✅ High-visibility role with approximately 90% of time spent supporting manufacturing operations
✅ Significant exposure to quality investigations, process improvements, and production support
✅ Open to candidates from medical device, pharmaceutical, combination product, automotive, and other regulated manufacturing environments
✅ Strong growth potential within a rapidly expanding organization
Compensation & Benefits
- Base Salary: $75,000 - $85,000
- Discretionary Bonus
- Equity potential
- Comprehensive benefits package
Salary : $75,000 - $85,000