Insight Global is seeking a dedicated Quality Engineer to support their client out of Raynham, Massachusetts. This individual will support day-to-day quality operations, including nonconformances (NRs), Corrective and Preventive Actions (CAPAs), and change management processes. They will be responsible for will working directly with operators on the manufacturing floor, conducting investigations, making informed quality decisions, and ensuring compliance with industry standards.
The selected candidate will be trained by an existing team member and expected to take ownership of routine quality functions while collaborating with engineers and operations personnel. This is a hands-on role, requiring a professional who thrives in a fast-paced, floor-heavy environment rather than a laboratory setting. This is an onsite, active role requiring a professional who is comfortable working directly on the manufacturing floor and collaborating with teams to drive quality initiatives.
Key Responsibilities:
Engage directly with operations and operators to oversee quality processes on the manufacturing floor.
Conduct investigations and root cause analyses related to nonconformances and finished goods.
Perform document reviews in the Device History Record (DHR) review room; escalate and resolve discrepancies.
Make informed quality decisions based on regulatory guidelines and company standards.
Support continuous improvement initiatives, control documents, redlining, and change order management.
Work within PLM and ERP systems for batch release and change control processes.
Train and coordinate quality-related approvals alongside senior personnel.
Ensure compliance with ISO 13485 & ISO 14000 standards and risk management protocols.
Assist with validation protocols, including IQ, OQ, PQ, TMVs as required.
The pay for this role ranges from 48/HR to 52/HR depending on skillset, experience and education.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com. The EEOC "Know Your Rights" Poster is available
here.
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Minimum 2 years of experience as a Quality Engineer or in a transferable role within a regulated industry.
Previous experience handling CAPAs and nonconformances.
Experience working with operators on the manufacturing floorsteel-toe environment, not lab-based.
Familiarity with PLM system & ERP for change management processes.
Strong decision-making and communication skills to navigate investigations and escalations.
Industryt experience in medical devices, aerospace or a highly regulated environment.
Experience with Windchill (change control, PLM system) and ETQ.
Prior exposure to validation protocols (IQ, OQ, PQ, TMVs).
Background in medical devices, pharma, or aerospace, with an interest in transitioning to med device.
Previous hands-on experience in process manufacturing.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.