Senior Quality Engineer

Team: Engineering

Location: Saco, Maine

Commitment: Full-Time

Workplace Type: onsite

What We Offer:

• Generous paid vacation and sick time 

• 8 paid holidays and 2 floating 

• Paid parental leave 

• Medical, dental, vision 

• HSA with employer contribution 

• 401k with employer match 

• Annual pay in the range of $95,000 - $120,000 

Qualifications:

• Bachelor’s degree in Quality Engineering, Manufacturing Engineering, Mechanical Engineering, or a related technical field; equivalent relevant experience may be considered. 

• Five or more years of quality engineering or manufacturing quality experience, preferably in a medical device manufacturing environment. 

• Hands-on experience with incoming, in-process, final, and outgoing inspection processes. 

• Working knowledge of ISO 13485 quality systems and medical device manufacturing requirements. 

• Experience using electronic Quality Management Systems (eQMS), SAP, and computer-aided quality systems; CAQ experience is preferred. 

• Experience managing inspection and measurement equipment and supporting calibration and maintenance controls. 

• Experience with engineering and production process development, process validation, and production transfers. 

• Ability to interpret drawings, specifications, acceptance criteria, inspection plans, and test results. 

• Demonstrated ability to work hands-on with Production, Engineering, Supply Chain, and other process owners to resolve quality issues and improve processes. 

• Strong written and verbal communication skills, with the ability to train personnel, lead working sessions, and collaborate effectively across the organization. 

Responsibilities and Scope:

• Own and continuously improve the incoming and outgoing inspection processes, including final-test review and product-release inspection activities. 

• Perform incoming, in-process, final-test, and outgoing quality inspections as workload and business needs require. 

• Manage quality inspection equipment, including equipment readiness, calibration status, maintenance coordination, and appropriate use. 

• Supervise and support execution of the inspection process to ensure requirements, records, and acceptance criteria are consistently applied. 

• Partner directly with process owners to update, document, implement, and improve quality processes within the QMS. 

• Implement and maintain processes in the CAQ Process module as needed. 

• Support engineering and production process development, validation, and transfer into manufacturing. 

• Implement process controls, inspection methods, test methods, and validation protocols for medical device manufacturing. 

• Support nonconformance, CAPA, risk management, change management, supplier quality, internal audit, and continuous-improvement activities. 

• Conduct training for Production, Engineering, and Quality personnel on inspection methods, quality processes, and applicable procedures. 

• Maintain accurate and complete quality records in the applicable eQMS, CAQ, and SAP systems.