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 **:In this exciting role as a Supplier Quality Engineer II, you will be responsible for the management of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of quality performance and process improvement activities. 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 device / component quality in conjunction and within our suppliers' quality systems.
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.
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.
Responsibilities may include the following and other duties may be assigned.
- Ensures that suppliers deliver quality parts, materials, and services.
- Work with Medtronic's strategic CM/OEM suppliers to lead and drive systematic approaches to medical device quality issues.
- Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
- Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities.
- Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes); leveraging the Production Part Approval Process (PPAP) when required.
- Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
- Ensure the resolution of all issues raised during testing/qualification.
- Drive corrective/preventative actions at our CMs/OEMs based on feedback from incoming inspection, production defects, Medtronic/supplier internal quality metrics and customer complaints.
- Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the supplier's Quality Management System.
- Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
- Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification.
- Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.
**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 to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
**DIFFERENTIATING FACTORS**
**Autonomy**:Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact**:Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
**Innovation and Complexity**:Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to s