Quality Engineer

Quality Engineer Lowell, MA (On site) Direct/Permanent Hire with Full Benefits Pay - Generally they like to stay around $85,000 - $90,000 but can go a bit higher for the right fit Strong benefit package and brand new building. Building has a gym with free membership for employees and brand new cafeteria on-site Quality Engineer Make an impact where quality actually matters. We’re looking for a Quality Engineer who enjoys solving problems, improving processes, and working closely with both engineering and production teams. This is a hands-on role where you’ll play a key part in ensuring products meet customer expectations and regulatory standards in a highly regulated manufacturing environment. You won’t just maintain quality systems; you’ll actively improve them. ________________________________________ What you’ll be doing •     Develop and improve quality processes that ensure products meet customer and regulatory requirements •     Create and maintain documentation such as SOPs, work instructions, control plans, PFMEAs, and inspection reports •     Act as the primary point of contact for customer validation activities •     Partner with Engineering and Operations to drive IQ/OQ/PQ and/or PPAP validation efforts •     Lead root cause investigations and CAPA activities using structured methods like 8D, 5 Whys, and Fishbone •     Support inspections, calibrations, audits, and production validations •     Monitor process performance, identify issues, and ensure corrective actions are implemented •     Analyze quality data and provide insights that drive real improvements •     Lead Material Review Board (MRB) activities and manage nonconforming materials •     Work cross-functionally to continuously improve processes and reduce defects ________________________________________ What we’re looking for •     2–4 years of experience in a manufacturing environment •     Familiarity with ISO 9001 and/or ISO 13485 •     Strong problem-solving skills and attention to detail •     Experience with measurement and inspection techniques •     Comfortable working with data and drawing meaningful conclusions (Minitab is a plus) •     Organized, self-driven, and able to manage multiple priorities in a fast-paced environment •     Strong communication skills and ability to work across teams Nice to have •     Experience with IQ/OQ/PQ or validation processes •     ISO auditing experience or certification ________________________________________ What to expect This role is a mix of desk work and time on the manufacturing floor. You’ll be analyzing data one minute and working side-by-side with production teams the next. It’s fast-paced, collaborative, and gives you real ownership over the quality of the product.