Supplier Quality Engineer II
About The Position
The Peripheral Vascular Health portfolio develops and manufactures technologies used to treat vascular disease, including peripheral stents and delivery systems. The Nathan Lane manufacturing site in Plymouth, Minnesota supports approximately 20 product families and works closely with suppliers to ensure the quality, reliability, and compliance of components used throughout the portfolio. This position is part of the Supplier Quality organization and partners with engineering, operations, and global quality teams to improve supplier performance, address quality risks, and support a stable supply chain. This is an onsite position based in Plymouth, Minnesota with an expectation of working onsite five days per week. Travel is expected to be 10% or less. As a Supplier Quality Engineer II, you will serve as a technical resource for supplier quality activities supporting the Nathan Lane manufacturing site. This role is responsible for resolving supplier quality issues, driving performance improvements across the supply base, and partnering with internal and external stakeholders to ensure compliant and effective quality systems.
Requirements
- Bachelor's degree and 2+ years of relevant experience in supplier quality, quality engineering, manufacturing engineering, or a related engineering discipline; OR Advanced Degree and 0+ years of relevant experience.
Nice To Haves
- Experience in the medical device industry or another highly regulated manufacturing environment, including supplier quality management, supplier controls, process validation, supplier auditing, failure investigations, nonconforming product controls, and technical documentation development.
- Working knowledge of Quality System Regulation (21 CFR Part 820), ISO 13485, corrective and preventive action (CAPA), risk management, change control, and supplier quality system requirements.
- Experience applying quality engineering tools and methodologies, including Failure Modes and Effects Analysis (FMEA), statistical quality control, process capability analysis, and Six Sigma principles.
- Professional quality certifications such as ASQ Certified Quality Engineer (CQE) or ASQ Lead Auditor certification.
- Strong communication and collaboration skills with experience influencing suppliers and cross-functional stakeholders; proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and Project.
- 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.
Responsibilities
- Lead investigations and resolution of supplier quality issues that impact product quality, manufacturing performance, or compliance requirements.
- Partner with suppliers to identify root causes, implement corrective and preventive actions, and verify effectiveness of improvements.
- Analyze supplier performance data and develop strategies to improve supplier quality, delivery performance, and process capability.
- Collaborate with engineering, operations, and quality teams to assess supplier-related risks and implement sustainable solutions.
- Support supplier qualification, change management, and ongoing supplier monitoring activities.
- Conduct supplier audits and evaluate supplier quality systems against applicable regulatory and company requirements.
- Drive continuous improvement initiatives focused on defect reduction, issue prevention, and supplier quality performance.
- Provide technical guidance and influence cross-functional teams on supplier quality strategies and decisions.
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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
