Senior Quality Engineer

Location: Saco, Maine, United States; on-site

Salary: $95,000–$120,000 annually

Company

hirify.global designs and manufactures high-precision optical systems, including medical endoscopes, for Life Sciences, Advanced Manufacturing, and Aerospace and Defense.

What you will do

• Own and continuously improve incoming, in-process, final-test, and outgoing inspection processes.
• Perform quality inspections and review final-test and product-release activities as required.
• Manage inspection equipment readiness, calibration status, maintenance coordination, and appropriate use.
• Maintain and improve QMS processes, including CAQ Process module implementation.
• Support engineering and production process development, validation, and manufacturing transfers.
• Support nonconformance, CAPA, risk management, change management, supplier quality, audits, continuous improvement, and personnel training.

Requirements

• Bachelor’s degree in Quality Engineering, Manufacturing Engineering, Mechanical Engineering, or a related technical field; equivalent experience may be considered.
• Five or more years of quality engineering or manufacturing quality experience, preferably in medical device manufacturing.
• Hands-on experience with incoming, in-process, final, and outgoing inspections.
• Working knowledge of ISO 13485 quality systems and medical device manufacturing requirements.
• Experience with eQMS, SAP, computer-aided quality systems, inspection equipment, calibration controls, process validation, and production transfers.
• Ability to interpret drawings, specifications, acceptance criteria, inspection plans, and test results, and collaborate with cross-functional process owners.

Culture & Benefits

• High-precision technical work within a small team where contributions are visible and ideas matter.
• Paid vacation and sick time.
• Eight paid holidays and two floating holidays.
• Paid parental leave.
• Medical, dental, vision, HSA with employer contribution, and 401(k) with employer match.