Position located in Burlington, MA.
Responsibilities of the Quality Engineer: Validate product operations, functions, and failures Isolate, reproduce, and resolve issues found on during production and with external clients Partake in all activities involving QA and regulatory compliance Assist regulatory team with both internal and supplier audits Review SOPs, batch records, change orders, CAPAs, and other documentation related to quality systems Inspect and analyze incoming parts Determine failure modes, risk analysis, and FMEAS Requirements of the Quality Engineer: BS in engineering related discipline Must have previous experience with medical device or quality inspection experience in other highly regulated industry Experience with high level troubleshooting Candidates should have quality experience with incoming suppliers Previous experience with both internal and external audits