About this role
Role Overview
- Ensure that suppliers deliver quality parts, materials, and services
- Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
- Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur
- Develop and prioritize 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
- Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation
- Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements
- Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 7 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5 years of work experience in Engineering and/or Quality OR PhD with 3 years of work experience in Engineering and/or Quality
- Experience supporting external contract manufacturers for finished medical devices, including oversight of supplier quality agreements, performance monitoring, and issue escalation
- Advanced knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and familiarity with global regulatory expectations
- Demonstrated experience leading complex supplier investigations, including root cause analysis, CAPA development, and implementation of corrective actions across multi-site supply chains
- Prior experience performing and leading supplier audits (onsite and remote), including certification as a lead auditor or equivalent training
- Experience implementing or reviewing Production Part Approval Process (PPAP) packages with suppliers or contract manufacturers, including evaluation of control plans, PFMEA, MSA, capability studies, and first article inspection results to support production readiness
- Certification or formal training in continuous improvement methodologies such as Lean, Six Sigma (Green Belt or higher), FTQ, or similar process improvement frameworks, with demonstrated application in supplier or manufacturing environments
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)