What are the responsibilities and job description for the Quality Engineer (W2) position at Redbock - an NES Fircroft company?
Sr. Quality Engineer (12 month contract // Grand Rapids, MI):
Onsite or hybrid (with mandatory 3 days onsite including Monday, Wednesday & Fridays with some rotation to support when necessary)
Top 3 Skills:
- Quality Engineer experience in a medical device setting
- Experience and capability to work in a fast-paced environment
- EU MDR compliance experience is strongly preferred
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.
Education Required: Bachelor’s Degree e.g. Biomedical Engineering, Mechanical Engineering, or similar
Years’ Experience Required: 2-4 years of direct EU MDR compliance/remediation experience
Duties:
- 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.
- Ensure proper prioritization of the various project deliverables at Grand Rapids site.
- 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.
Required Skills:
- Advanced Project Quality Engineering experience, including support for various quality and manufacturing set up for new products
- Experience with Capital Projects, including validation and IQ/OQ/PQ
- Experience developing and implementing new product inspection methods
- Prior experience with EU MDR Remediation or new product introduction for EU MDR compliant products
