Quality Engineer at EDA Staffing

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.