Quality Engineer II

Medtronic • Louisville, CO

3d • Onsite

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 At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as Quality Engineer II, you will be a part of the Americas Service & Repair team at our Louisville, CO site. Service of medical devices is crucial to ensuring their safe and effective operation, which ultimately allows healthcare professionals to deliver reliable and high-quality care to their patients. You will be an integral part of the team that supports the company’s quality policy to Put Patients First. This team collaborates with global teams to support products across several portfolios in Medtronic. Responsibilities may include the following and other duties may be assigned: Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of production control, product evaluation and reliability, and/or inventory control as they apply to product or process quality. Implement corrective and preventive actions (CAPA) to address quality issues and ensure documentation is complete and compliant with requirements. Support production control, product evaluation, reliability analysis, and continuous improvement initiatives across assigned product or process areas. Support virtually the Quality Walks Improve Quality (QWIQ) program at Louisville depot. Support NCMRS (nonconformances) for the Louisville depot. Conduct Material Review Board (MBR) meetings for Louisville depot.

Requirements

• Bachelor’s degree in engineering or a Science-related field, with 2+ years of relevant experience in Engineering and/or Quality; OR Master's degree with a minimum of 0 years relevant experience.
• 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.

Nice To Haves

• Training or experience in Root Cause Analysis, NCMRs, and Audit Readiness (internal and external audits).
• Nonconformances and CAPA (Corrective Action and Preventive Action) experience.
• Demonstrated experience with CAPA management and quality system improvements.
• Experience creating, implementing, and maintaining process improvements, documentation, and change controls.
• Experience in manufacturing environment within Medical Devices or Pharmaceutical industries.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of production control, product evaluation and reliability, and/or inventory control as they apply to product or process quality.
• Implement corrective and preventive actions (CAPA) to address quality issues and ensure documentation is complete and compliant with requirements.
• Support production control, product evaluation, reliability analysis, and continuous improvement initiatives across assigned product or process areas.
• Support virtually the Quality Walks Improve Quality (QWIQ) program at Louisville depot.
• Support NCMRS (nonconformances) for the Louisville depot.
• Conduct Material Review Board (MBR) meetings for Louisville depot.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and 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: Mid Level
• Number of Employees: 5,001-10,000 employees