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The Quality Systems Specialist will support ISO 13485-certified QMS, manage CAPA processes, conduct audits, monitor and analyze quality systems, and ensure compliance with regulatory standards in a medical device company.

The Supplier Engineer will manage root cause investigations, execute assembly validations of new supplier tooling, implement improvement projects, and assist in resolving quality issues related to supplier components. They will establish vendor relationships and lead cross-functional teams towards continuous improvement goals in a factory setting.

The Failure Analysis Engineer will conduct post-market investigations of FDA-approved medical devices, ensuring compliance with quality standards and collaborating with cross-functional teams to perform root cause analysis on failures. Responsibilities include product testing, maintaining quality records, and assisting during regulatory inspections while driving process improvements with Lean Six Sigma methodology.