What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
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.
- Bachelor's 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.
