The Senior Quality Engineer to join the team, will work with cutting-edge orthopedic and software surgical devices. This role involves ensuring product quality and compliance from design through manufacturing.
Key Responsibilities:
- Represent Quality Assurance in product design and development projects.
- Ensure compliance in manufacturing and repair activities.
- Lead quality process improvements and analyze trends.
- Approve and document product and process changes.
- Manage nonconformance resolutions and corrective actions.
- Support and mentor quality team members.
Qualifications:
- Bachelor's degree in Engineering required.
- 5+ years in Quality Control/Assurance, ideally in medical devices.
- Experience with capital equipment and software validation REQUIRED.
- Proficiency in risk assessments, design control, SPC, and process improvement.
- Knowledge of FDA, ISO13485, ISO14971, and medical device regulations.
- Lean Six Sigma Belts preffered
If you are interested and would like to learn more, send your resume to [email protected]
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