At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Senior Quality Engineer focuses on aspects of product quality and reliability for products that are in the field and that are part of Medtronic Neuromodulation/Pelvic Health organization. In this role, you will participate in activities related to internal supplier process assurance, data review, issue investigation on Neuromodulation/Pelvic Health products, components, and services. The Senior Quality Engineer assures that applicable processes, specifications and records meets the regulations, standards and regulatory expectations, and that documentation is compliant with requirements.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Represent Neuromodulation/Pelvic Health to provide quality oversight with Medtronic internal component, finish product, distribution centers, and supporting services.

• Collaborate with the different internal sites and services to execute processes including change control, product/component/process non-conformances, and CAPA.

• Collaborate with suppliers to close out audit findings or corrective actions.

• Lead or support investigations of nonconformance for supply chain, operations distribution centers and supporting laboratories.

• Respond to audit findings with effective preventive and corrective actions.

• Support both internal and external audits.

• Lead or participate in product, business process or quality system level improvement initiatives and activities including Neuromodulation initiatives and sector system development.

• Provide training and coaching as needed, to internal suppliers, or Medtronic personnel on Quality System Regulation, ISO, Combination products, and Neuromodulation quality systems requirements.

• Facilitate issue escalations for internal suppliers with internal boards and monthly metrics reviews with supporting suppliers.

• Collaborate with different departments across the organization to support data review for manufacturing changes, NCMRs, CAPAs, technical transfer documents.

• Represent the Neuromodulation/Pelvic Health organization as the primary contact for the internal suppliers for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA among others.

• Ensures that corrective measures meet acceptable reliability standards.

• As necessary, proposes changes in design or formulation to improve system and/or process reliability.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality

• OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

Nice to Have

• Bachelor’s Degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related science.

• Experience in medical devices or other highly regulated industry such as defense or automotive.

• Experience in quality, supply chain, manufacturing, design assurance, safety, or systems engineering.

• Experience with and knowledge of medical device standards including ISO 13485.

• Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)

• Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships

• Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude

• Ability to lead cross-functional teams and drive discussion and decision-making.  This includes facilitation, consensus building and conflict resolution.

• High degree of initiative and self-motivation

• Strong attention to detail and accuracy

• Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks

• Strong analytical skills and the ability to solve problems through analytical reasoning.

• ASQ Certification in a Quality discipline is a plus.