Senior Supplier Quality Engineer

Medtronic • Asheville, NC

9d • $99,200 - $148,800 • Remote

About The Position

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 Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. In this exciting role as a Senior Supplier Quality Engineer, you will be responsible for supporting the oversight of manufacturing which occurs at the Medtronic strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs), with accountability to support changes to existing supplied products and processes, as well as oversight of nonconformances and complaint investigations performed by the suppliers. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical devices / component quality in conjunction and within our suppliers’ quality management systems. This role will require 25% of travel to various Contract Manufacturers and OEMs. You will work in partnership with the internal Medtronic R&D, Quality, and Regulatory teams, to ensure our supplied products conform to finished device requirements, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements. This role is responsible for ensuring all aspects of the manufacturing process produce products to the highest possible reliability and quality. As a Senior Supplier Quality Engineer level, you will work independently under limited supervision as a seasoned individual contributor addressing difficult challenges at a supplier level. Problem-solving is in-depth, requiring innovative solutions, process improvements, and project or change management skills. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 25% of travel to enhance collaboration and ensure successful completion of projects.

Requirements

• 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 OR PhD with 0 years relevant experience

Nice To Haves

• Experience supporting supplier change management in the medical device industry, including familiarity with Medtronic Supplier Change Request (SCR) processes and regulated change management systems.
• Strong knowledge of regulatory and quality requirements including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971 risk management principles.
• Experience working with OEM suppliers, contract manufacturers, and sub-tier suppliers in regulated environments, including supplier risk assessments, supplier audits, supplier performance monitoring, and supplier development.
• Demonstrated experience evaluating design changes, manufacturing transfers, process validations, and supplier-driven process changes.
• Expertise in validation and process qualification activities including IQ, OQ, PQ, and TMV, with working knowledge of manufacturing assembly processes and inspection/testing methods.
• Working knowledge of statistical and quality engineering tools including Design of Experiments (DOE), Measurement System Analysis (MSA), Process Capability, and Statistical Process Control (SPC).
• Experience with quality system processes including nonconformance management, UAI dispositions, failure investigations, and nonconforming product controls.
• Knowledge of continuous improvement methodologies including First Time Quality (FTQ), Lean, and Six Sigma principles.
• Proven project management experience with the ability to manage multiple supplier change requests simultaneously in fast-paced environments.
• Strong cross-functional collaboration with Quality, Regulatory, Operations, and R&D teams, along with effective stakeholder management when working with global teams and external suppliers.
• Excellent organizational, planning, technical writing, communication, and presentation skills, with the ability to work effectively in team and partnership environments.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Ensure that suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborate with Component Engineers 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.
• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior