Quality Engineer II - Exempt
- Billerica, MA
- Permanent
- Full-time
Client: Medical Device Manufacturing Company
Duration: 7 months (possible extension)
Location: Billerica, MA 01821
Shift: On-site, 2nd shift (Mon Fri, 2pm 10pm)DescriptionWe are seeking a Quality Engineer II to support 2nd shift operations. This role focuses on driving higher quality standards in manufacturing, supporting CAPAs and non-conformances, and ensuring compliance with protocols and regulatory requirements.Responsibilities
- Execute CAPAs and manage Non-Conforming Material Reports
- Serve as the Quality representative for 2nd shift manufacturing
- Develop, apply, and maintain quality standards & protocols
- Collaborate with engineering and manufacturing teams
- Implement methods for inspection, testing, and evaluation
- Design/specify testing mechanisms & conduct QA tests
- Perform statistical analysis of product/equipment quality
- Ensure corrective measures meet reliability standards
- Prepare compliant documentation per regulations
- May specialize in design, production control, incoming material, product evaluation, or R&D quality
- Electrical Engineering background
- Capital manufacturing experience
- Non-conforming product control
- CAPA expertise
- Strong communication and influence skills
- Education: Bachelor's in Engineering (required)
- Experience: 2+ years (or advanced degree with 0 years)
- Works independently with general supervision
- Contributes to project milestones and quality improvements
- Engages in cross-functional collaboration
- Provides guidance to junior professionals
- Communicates with internal stakeholders to share information & resolve issues
- Applies practical knowledge in a moderately complex environment