Quality Engineer
Location: Raynham, MA (On-site, 5 days per week)
Job Type: 12-month Contract
Bill Rate: (Need confirmation)
Interview Process: One round with hiring manager on Teams (45 minutes)
Industry: Medical Device / Regulated Industry
Overview:
Insight Global is seeking a dedicated Quality Engineer to support their client in 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 work directly with operators on the manufacturing floor, conduct investigations, make informed quality decisions, and ensure compliance with industry standards.
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.
Must-Have Qualifications:
- 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 floor-steel-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.
- Industry experience in medical devices, aerospace, or a highly regulated environment.
Preferred Qualifications (Pluses):
- 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.