We anticipate the application window for this opening will close on - 13 Aug 2025

 

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

Develop and execute strategies to oversee and improve all quality-related activities for Contract Manufacturers (CMs).
Build and maintain a robust strategy for managing CMs, ensuring alignment with business objectives and quality standards.
Collaborate with CMs to develop and maintain technical quality assurance systems such as MSAs, SPC, Quality Plans, and FMEAs.
Support continuous improvement initiatives to enhance supplier quality processes globally.
Lead Production Part Approval Process (PPAP) qualifications for CMs.
Drive Supplier Optimization and Risk Reduction (SOAR) initiatives.
Manage qualifications of changes, including process, material, or tooling changes, and oversee associated change control activities.
Implement and monitor CM development initiatives such as performance management, process improvements, cost reduction, and Six Sigma/Lean integration.
Evaluate CM performance, recommend improvements, and report on quality metrics to company management.
Ensure CM compliance with Medtronic Quality Systems, ISO standards, and FDA 21 CFR part 820 regulations.
Manage Supplier Corrective Action Requests (SCARs) and ensure proper documentation practices for Supplier Change Requests (SCRs).
Facilitate customer complaints related to CM products and ensure thorough investigations and corrective actions.
Perform deviation investigations into quality issues arising from CM activities.
Partner with NPD teams to evaluate and understand future CMs’ quality plans and capabilities for new products.
Foster effective "partnerships" with preferred CMs to drive optimal performance, mutual trust, and financial success.
Promote a culture of continuous improvement and quality excellence within CM relationships.
Develops and prioritizes 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.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Nice to Have:
Must be a certified Auditor.
Must have experience in adding new suppliers to the ASL.

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

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes 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.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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.
• Provides 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.
• Collaborates 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.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor