MDR - Sr Quality Engineer - Exempt

Advanced Project Quality Engineering Specialist

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.

Top 3 technical skills that are required for the role:

• Quality Engineer experience at medical device
• Work in the fast pace environment
• MDR experience is preferred

Education Required:

University degree e.g. Bio medical Engineering, mechanical engineering, Biology, or similar.

Years' Experience

Required:

2

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite or hybrid (with mandatory 3 days onsite including Monday, Wednesday & Fridays or rotation to support when necessary)

What is your timeline for scheduling interviews? As soon as possible

What product line will this person support? Cardiac Surgery

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.

SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).