Quality Engineer
Quality Engineer
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1 Vacancy
Job Description
- Quality Engineer w/ Design Quality Engineering experience product quality support design verification & Risk Management (ISO 14971) Failure Assessment (FMEA) MUST HAVE Medical Device experience.
- Quality Engineer will be a part of the clients Diabetes Post-Market Quality Engineering team.
- This individual will primarily support quality deliverables for design changes second sourcing and manufacturing improvement projects.
- This individual will also quality deliverables such as technical reviews design assessments design verification plans and reports and maintenance of risk management documentation for on-market Diabetes devices.
- This individual should be a good collaborator able to take direction from other technical team members / PMO and split time between several projects and teams.
- May include the following and other duties may be assigned. Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Bachelors in engineering science or technology discipline.
- Years Experience Required: 4-10 years preferred.
- Design Quality Engineering experience.
- Highly prefer product quality support or design verification experience.
- Risk Management / Failure Assessment experience.
Employment Type
Full-time
