Quality Engineer
- Employer
- Commonwealth Sciences, Inc.
- Location
- Boston, MA
- Closing date
- Sep 23, 2021
View more
- Sector
- Science, Physical Sciences and Engineering
- Organization Type
- Corporate
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Position located in Burlington, MA.
Responsibilities of the Quality Engineer:
Requirements of the Quality Engineer:
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
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