Engineer Sr. I QA Supplier - ACT

Hongkang Northamerica-posted 3 months ago
$110,000 - $163,344/Yr
Full-time • Mid Level
Santa Barbara, CA
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Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Engineer - QA Supplier for our Santa Barbara facility. The Senior Quality Engineer is responsible for managing supplier activities related to nonconformances and CAPAs, sustaining and development, inspection alignment, and product disposition. The ideal candidate will have an Engineering degree and 5+ years in a Supplier Quality Engineering role within a regulated industry. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  • Understand and apply external regulatory and internal QMS requirements for Supplier Quality.
  • Accountable for supplier-caused nonconformances, including, but not limited to, nonconformance coordination, containment of nonconforming material, evaluation of nonconforming material, and execution of action plans.
  • Drive supplier Corrective and Preventative Actions (CAPAs) and/or owns supplier-facing action plans, including assisting suppliers with CAPAs.
  • Responsible for assisting in complaint investigations related to product quality from suppliers.
  • Provide pertinent information as requested by auditors to assist with external audits of Arthrex or suppliers.
  • Participate in Supplier, part or inspection qualification.
  • Hold workshops, regular cadence meetings, and other events to drive alignment and improvement with suppliers.
  • Works with suppliers to ensure that established requirements are being facilitated and met at the supplier's location.
  • Gather and present data to leadership monthly for team/site performance.
  • Report progress and status of assigned projects on a timely basis.
  • Bachelor's degree in Engineering required
  • 5+ years relevant experience required
  • Broad knowledge of FDA and ISO guidelines required
  • Broad manufacturing process knowledge required
  • Qualified ISO 13485/MDSAP Lead Auditor preferred
  • Project management and communication skills training preferred
  • Broad technical knowledge in supplier development, inspection methods, design for manufacturing, and supplier corrections and corrective actions
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Lunch
  • Gym Reimbursement Program
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Paid Sick Leave
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
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