What are the responsibilities and job description for the MDR - Sr Quality Engineer position at Grove Technical Resources, INC?
Job Title - MDR - Sr Quality Engineer
Job Location - Grand Rapids, Michigan
Job Description -
This position will support all cardiac surgery EU MDR implementation projects to create/ review and approve change orders, redline the technical documentation, actively lead the label verification process in collaboration with quality engineers at Grand Rapids. Support all other EU MDR related deliverables for the MDR team as appropriate.
Must Have
- Advanced Project Quality Engineering Specialist
Nice To Have
- EUMDR experience
Top 3 technical skills that are required for the role:
- Quality Engineer experience at medical device
- Work in a fast-paced environment
- MDR experience is preferred
Responsibilities 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. Accountable for the successful implementation of the outcomes the EU MDR implementation projects, EU MDR remediation assignment.
- Prioritization of the projects deliverables at Grand Rapids. Support label verification process, inspection, FAI, and other Grand Rapids related QE activities to move the MDR projects in a timely manner.
- Review and approve change orders that are related to MDR projects and ensure the quality aspect of the projects are reviewed and in compliance.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed).
- IQ, OQ and PQ performance and review if needed. 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.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
