Supplier Quality Engineer II
Medtronic
Summary
The Supplier Quality function supports enterprise operations by partnering with suppliers and cross-functional engineering and manufacturing teams to ensure purchased parts, materials, and services meet quality requirements throughout the product lifecycle. This position is based at Medtronic's Brooklyn Park, Minnesota site and requires onsite work five days per week.
Job description
Primary Responsibilities
- Ensure suppliers deliver parts, materials, and services that meet established quality requirements.
- Qualify suppliers according to company standards and support receiving inspection and supplier quality programs.
- Monitor supplier parts throughout the manufacturing cycle and drive resolution of supplier-related quality issues.
- Develop and prioritize supplier audit schedules and conduct audits against Good Manufacturing Practice (GMP) and applicable quality standards.
- Evaluate supplier processes and quality systems, communicate findings, and drive appropriate improvements.
- Provide Supplier Quality Engineering support throughout the New Product Development lifecycle for newly qualified parts.
- Partner with Component Engineering and Post-Market Supplier Quality teams on product acceptance sampling strategies, Approved Supplier List coordination, Supplier Owned Quality deployment, and control plans.
- Define receiving inspection requirements and support validation of applicable internal test methods.
Required Qualifications
Bachelor's degree in Engineering, Science or technical field and 2+ years of relevant experience OR master's degree in Engineering, Science or technical field with 0+ years of relevant experience.
Preferred Qualifications
- Medical device industry experience and working knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820.
- Experience applying Define, Measure, Analyze, Improve, and Control (DMAIC) or Lean Six Sigma principles; Green Belt or Black Belt certification preferred.
- Statistical data analysis experience, including Statistical Process Control (SPC), root cause analysis, and problem-solving methodologies.
- Experience with risk management, Corrective and Preventive Action (CAPA), or Automated Optical Inspection (AOI) validation.
- Experience interfacing with internal customers, suppliers, and external regulatory agencies.
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.
Requirements
- Bachelor's degree in Engineering, Science or technical field and 2+ years of relevant experience OR master's degree in Engineering, Science or technical field with 0+ years of relevant experience
- Medical device industry experience
- Working knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820
- Experience applying DMAIC or Lean Six Sigma principles
- Green Belt or Black Belt certification preferred
- Statistical data analysis experience including SPC, root cause analysis, and problem-solving methodologies
- Experience with risk management, CAPA, or AOI validation
- Experience interfacing with internal customers, suppliers, and external regulatory agencies
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.