Quality Engineer II
Quality Engineer II
Posted on :
05-06-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Execute Design Verification/Validation Strategies with emphasis on.
- Technical analysis of requirements specifications and control strategy.
- Alignment of design outputs to production and process controls.
- Proper verification techniques including inspection demonstration test etc.
- Lead design characterization activities for development projects.
- Support design test and inspection method development and lead method validation activities.
- Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred.
- 3-5 years Engineering experience with new product development.
- Experience in supplier controls critical quality attributes and tracing design outputs to implemented supplier processes.
- Working knowledge on design verification and design validation techniques.
- Working knowledge of applied statistics sampling strategies and design of experiments including statistical software tools such as Minitab.
- Strong organizational and follow-up skills as well as attention to detail.
- Ability to collaborate on-site on a regular basis.
- Knowledge of FDA IEC 60601 GMP ISO 13485 and ISO 14971.
- Prior medical device experience preferred.
Employment Type
Full Time
Key Skills
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