Senior Quality Engineer

Skillcloud HCM • Saco, ME

9d • $95,000 - $120,000 • Onsite

About The Position

FISBA is seeking a Senior Quality Engineer to be based in their Saco, Maine facility. This hands-on role owns the incoming and outgoing inspection processes, performs quality inspections as needed, manages inspection equipment, and supports effective execution of inspection activities. The Senior Quality Engineer also works closely with process owners to maintain and improve the Quality Management System (QMS), implements processes in the CAQ Process module as needed, and supports engineering and production process development and production transfers.

Requirements

• 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.

Nice To Haves

• CAQ experience is preferred.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior