Supplier Quality Engineer II

🔥 0 minutes ago

⛰️ Colorado, Massachusetts – Remote

⛰️ Colorado – Remote 🍂 Massachusetts – Remote

💵 $80k - $120k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

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Medtronic

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1949

⚕️ Healthcare Insurance

Healthcare Insurance • Medical Devices

Medtronic is a global leader in healthcare technology solutions, working to address the most complex and challenging medical conditions. With over 95,000 employees in more than 150 countries, the company is focused on accelerating access to healthcare technologies and advancing inclusion, diversity, and equity in healthcare. Medtronic collaborates closely with healthcare professionals to innovate and optimize treatments and therapies, thus inspiring hope and new possibilities for patients worldwide. The company's commitment to healthcare extends to its focus on impactful solutions and sustainable practices.

📋 Description

• As a Supplier Quality Engineer II, you will play an important role on cross-functional core teams supporting all Medtronic's sites and regions. • This position is 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. • Some individuals may have responsibilities that include Pre-Market Supplier Quality.

🎯 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)