Sr Supplier Qual Engineer
A career at Medtronic is like no other. We’re committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Responsibilities may include the following and other duties may be assigned.
- Ensure suppliers deliver quality parts, materials, and services.
- Qualify suppliers according to company standards.
- Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
- Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
- Evaluate suppliers' internal functions to assess overall performance and provide feedback.
- Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.
- Collaborates to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- Lead suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
- Manage the Approved Supplier List, including administrative work in MAP Agile.
- Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
- Improve suppliers' performance and reduce escapes to manufacturing.
- The job may require travel to suppliers within the United States and internationally.
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelors degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter/Disposable SQE position.
- Medical device manufacturing industry experience, preferably ISO 13485.
- Lead auditor experience.
- Hands-on experience with SAP, Trackwise, Agile change management.
- Ability to manage tasks and projects under tight deadlines with a sense of urgency.
- Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
- Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
- Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
- Engage in changes and advocate for inclusions/diversity.
- Preference given to master’s degree in mechanical, Biomedical, or Manufacturing Engineering, Engineering Technology or related engineering field, and two (2) years’ experience as a supplier, quality, or manufacturing engineer or related occupations. OR bachelor’s degree in mechanical, Biomedical, or Manufacturing Engineering, Engineering Technology, or related engineering field, and five (5) years’ experience as a supplier, quality, or manufacturing engineer or related occupations.
- ASQ CQE, CQA and/or CSQP certification
- First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
- Possess a minimum of 2 years’ experience with each of the following:
- Supplier Change Process evaluation and implementation
- CAPA, Supplier related Product and Process NCMR
- Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews.
- Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T
- IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method Validations, and Measurement System Analysis.
- Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls
- GMP for Class II and Class III medical devices.
- FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 & ISO 14971.
- Supplier Change Process evaluation and implementation
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Operations Incentive Plan (OIP) here.
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
