Role OverviewThis role provides Quality Engineering support across operations while helping oversee the company's Quality Management System. Working closely with a lean, multidisciplinary team, the Quality Engineer will ensure ongoing compliance with FDA QMSR requirements and ISO 13485 standards while driving continuous improvement across all quality functions.
What You Will Do
Key responsibilities include maintaining and improving a QMSR and ISO 13485-compliant QMS, supporting development and revision of SOPs, managing document control and records management, participating in internal audits, leading or supporting CAPA investigations, and developing quality metrics and data analysis.
Why It Might Be a Fit
The ideal candidate will have a proven track record implementing, evolving, and improving QMS programs compliant with FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971, and will be comfortable working in a small company environment where adaptability and initiative are essential.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 5+ years of quality systems experience within a medical device manufacturing organization
- Proven track record implementing, evolving, and improving QMS programs compliant with FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971
- Demonstrated end-to-end QMS ownership including CAPA, document control, complaint handling, internal auditing, and supplier quality
- Strong technical writing skills with the ability to produce clear, compliant documentation
- Experience with statistical techniques, sampling plans, and data analysis for validation and process capability studies
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