8D, Auditing, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Data Analysis, Detail Oriented, Documentation, ISO (International Organization for Standardization), ISO 9001, Identify Issues, Manufacturing, Materials Management, Minitab, Multitasking, Organizational Skills, Performance Analysis, Problem Solving Skills, Process Improvement, Process Validation, Production Part Approval Process (PPAP), Quality Engineering, Quality Management, Regulations, Regulatory Requirements, Root Cause Analysis, Standard Operating Procedures (SOP), Systems Maintenance, Team Player
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.
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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
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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
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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.