Role: Quality Engineer
Location: Lexington, MA
Length: 12-month contract to hire
*Hybrid role is acceptable (2/3 days remote, 2/3 days onsite - going onsite during audits and sharing data is a MUST)
The Quality Engineer will work in the Regulatory Affairs and Quality Assurance space, with a focus on quality improvement. This position will identify quality systems process improvements, evaluate quality satisfaction, analyze info, report research results, develop and implement different standards, and manage processes.
Key Responsibilities:
- Responsible for process risk assessment, process improvement, scale-up, and validation readiness and packaging operations
- Perform statistical analysis for product assessment
- Streamline different processes to improve quality of products
- Implement different procedures to help reduce production waste in the facility
- Aid with change requests and CAPAs
- Attend meetings such as MRB (Material Review Board) and NCMR (Non-confirming Material Review)
- Use tools such as voltmeters, gauges, and micrometers to measure and analyze products in a lab environment
- Communicate and collaborate with other quality engineers to determine best production practices
Qualifications:
- Bachelor's degree required
- 3-5 years of process engineering experience
- Previous experience with producing medical devices is preferred
- Previous experience in Quality Assurance - documentation experience and working in an audit-ready environment
*W2 ONLY
*Again, this is a contract to hire opportunity, candidates must be local or open to relocation
*Benefits are provided
*Client requires all employees to be fully vaccinated
