Supplier Quality Engineer II
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Job Description
Supplier Quality Engineer II at Medtronic focusing on supplier quality agreements and compliance. Collaborating with cross-functional teams to ensure suppliers meet quality and regulatory standards.
Responsibilities:
- Play an important role on cross-functional core teams supporting all Medtronic's sites and regions.
- Responsible for negotiating, reviewing, and approving Quality Agreements with suppliers to ensure alignment on quality system requirements, regulatory compliance, and operational responsibilities.
- 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.
- Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD.
Requirements:
- Requires a Baccalaureate degree and minimum of 2 years of relevant quality experience OR Master's degree with a minimum of 0 years relevant experience.
- Prior knowledge with ISO13485 standards
- Experience negotiating and finalizing Quality Agreements with external suppliers
- Strong knowledge of supplier quality requirements and applicable regulations
- Ability to interpret quality system requirements and translate them into contractual obligations
- Excellent written and verbal communication skills
- Proven cross-functional collaboration with sourcing, legal, regulatory, and operations teams
- Strong risk assessment, issue resolution, and decision-making capabilities
- High attention to detail in document review, redlining, and approval workflows
- 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.
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)
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