SSE Academy
Senior Quality Engineer
Devens, MA, US · Senior
Sponsorship not specifiedDetected 71 days ago
ComplianceProduct ManagementAuditingSupply ChainMedical DevicesCommunicationProblem SolvingMentoringInternal Audit
About the role
- Key accountabilities include: Supervise your designated team.
- Work closely with the validation technical SME to ensure effective verification and validation (V V) of new products and processes within the NPI lifecycle.
- Champion thorough investigation of nonconformities using our eQMS Quality Event process, including product non-conformances, process deviations, and customer complaints.
Requirements
- Skills/Experience Bachelor's degree in engineering, or a scientific discipline.
- Minimum of 5 years' experience in Quality Assurance within a regulated industry.
- Proven working knowledge of ISO 13485 and ISO 9001 standards.
- Strong ability to engage and communicate effectively with cross-functional stakeholders.
- Demonstrated expertise in product and process validation methodologies.
- Established track record in driving continuous improvement initiatives and applying lean methodologies.
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