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Quality Engineering Technician - Zimmer Biomet
Software Engineer
Quality Engineering Technician ensuring medical device compliance through rigorous QA, Six Sigma methodologies, FDA regulations, and ISO 13485 standards, driving continuous improvement and robust documentation.
About the role
Key Responsibilities
- Execute quality audits and inspections to verify compliance with FDA regulations and ISO 13485 requirements.
- Apply Six Sigma tools and root cause analysis to identify process defects and implement corrective actions.
- Develop and maintain detailed quality documentation, including CAPA reports, change control records, and validation protocols.
- Collaborate with cross‑functional teams to support product development, design control, and risk management activities.
- Analyze statistical process control data to monitor and improve manufacturing performance.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Minimum 2 years of quality engineering experience in medical device or regulated industry.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GxP principles.
- Proficiency with Six Sigma methodologies and statistical analysis tools.
- Excellent communication, documentation, and problem‑solving skills.