Quality Engineer

Updated October 1, 2026 At a glance Company: Fusion Life Sciences Technologies LLC Location: Marlborough, MA 01752 Pay: $40 – $45 per hour Job Type: Contract (6 months) Experience: 5+ years Why this job is worth considering This Quality Engineer opening supports FDA remediation work inside a regulated medical-device manufacturing environment in Marlborough, MA. You'd investigate deviations and nonconformances, run root cause analysis, and own CAPA activities through closure, while partnering across Manufacturing, Quality, Engineering, Validation, and Operations to implement corrective actions. The role also touches process improvement, process validation, equipment qualification, and audit and regulatory-inspection readiness. It's a strong fit if you want hands-on ownership of root cause and CAPA work rather than a purely administrative quality role. This is a 6-month contract paying $40–$45 per hour, with a 5+ year baseline and a real preference for candidates with 10+ years in regulated manufacturing. What you'll be doing Support FDA remediation activities related to manufacturing and quality processes. Investigate manufacturing deviations, nonconformances, and quality issues. Perform detailed root cause analysis (RCA) and identify systemic and contributing causes. Develop, implement, and track CAPA activities through successful closure. Partner with Manufacturing, Quality, Engineering, Validation, and Operations teams to implement corrective actions. Support process improvements, process validation, equipment qualification, and manufacturing-readiness activities as applicable. Review and update manufacturing procedures, work instructions, specifications, and technical documentation. Analyze quality and manufacturing data to identify trends, recurring issues, and potential risks. Support audit and regulatory inspection readiness. What we're looking for Required Bachelor's degree in Engineering, Quality, Manufacturing Engineering, Mechanical Engineering, or a related technical field. 5+ years of experience, with strong exposure to the medical-device industry and FDA remediation activities. Hands-on experience with root cause analysis, deviation investigations, CAPA, nonconformances/NCRs, corrective and preventive actions, change control, risk assessment, and process improvement. Strong understanding of FDA medical-device requirements and quality management systems. Experience working with cross-functional Manufacturing, Quality, Engineering, and Operations teams. Strong technical documentation and problem-solving skills, with the ability to independently investigate complex manufacturing and quality issues. Preferred 10+ years of experience in Manufacturing Engineering, Quality Engineering, or related regulated manufacturing functions. Experience with FDA 483, Warning Letter, audit findings, or remediation programs. Experience with FDA 21 CFR Part 820/QMSR and ISO 13485. Experience with process validation and equipment qualification. Experience in sterile/aseptic or controlled manufacturing environments. Lean/Six Sigma experience or certification. Experience supporting regulatory inspections and quality-system remediation. Pay, benefits and schedule $40–$45 per hour, on a 6-month contract. About Fusion Life Sciences Technologies LLC and apply Fusion Life Sciences Technologies LLC is a staffing and workforce-solutions firm placing engineers and technical professionals with regulated life sciences, medical device, and pharmaceutical companies, with clients worldwide. Placements are made on a W2 basis, not as 1099 contractors, and Fusion's work spans manufacturing process setup, quality and compliance, regulatory affairs, and FDA remediation governed by frameworks like 21 CFR Part 820, ISO, GAMP, and USP. This Quality Engineer role is a client placement supporting FDA remediation work at a regulated medical-device manufacturing site. #J-18808-Ljbffr