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Quality Engineering Specialist Entry Level - Kelly Services
Software Engineer
Entry‑level Quality Engineering Specialist reviewing production records, managing non‑conformance, and supporting quality documentation in an FDA‑regulated, ISO 13485 environment.
About the role
Key Responsibilities
- Review and audit production records to ensure compliance with FDA and ISO 13485 standards.
- Assist in non‑conformance management, including root cause analysis and corrective action implementation.
- Support the creation and maintenance of quality and training documentation.
- Collaborate with cross‑functional teams to drive continuous process improvement.
- Participate in internal and external audits, preparing necessary documentation and reports.
Requirements
- Strong understanding of FDA regulatory requirements and ISO 13485 quality systems.
- Excellent analytical and documentation skills.
- Ability to work independently and as part of a multidisciplinary team.
- Detail‑oriented with a focus on operational excellence.
- Preferred: experience in a regulated medical device or pharmaceutical environment.
Skills
process improvement