Principal Quality Engineer
Responsibilities of the Principal Quality Engineer:
- Perform corrective, preventive, and closure actions for quality and/or test non-conformance.
- Partake in new product development to ensure proper quality plans are in place.
- Establish design assurance for proper compliance from concept to manufacturability of products.
- Enforced controls to be compliant with ISO 13485 and FDA QSR requirements.
- Ensure quality reporting is documented with the team.
- Perform analysis of reports and production data.
- Determine quality improvement parameters relevant to manufacturing processes.
Requirements of the Principal Quality Engineer:
- BS or MS is Engineering or Scientific discipline with 7+ years industry experience.
- Medical Device experience in a quality role is required.
- Must show prior experience working with in product development environment through several stages of product life cycle.
- Knowledge of Quality Engineering methodologies such as Design and Process Validation, Risk Management, Quality Systems, Continuous Improvement, and Corrective and Preventive Action.
- Knowledge of customer complaints, CAPA, audits processes.
- Knowledge of ISO 9001 and ISO 13485 standards and FDA regulations.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.