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Supplier Quality Engineer

Andover, United States

Job Description:
POSITION SUMMARY
The Supplier Quality Engineer will work closely with our suppliers and purchasing group to focus on our drive to deliver the highest quality products to meet the company’s mission and vision to save more lives. This position is responsible for strategic quality systems, investigating, analyzing and correcting problems in quality, production and control at a supplier location as well as perform audits and implement new strategies.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
  • Lead supplier related nonconformance investigation, MRB process and RMA process.
  • Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process.
  • Partner with R&D engineering to identify and qualify new suppliers.
  • Report on supplier Key Performance Indicators (KPIs).
  • Manage the Approved Supplier List (ASL) and supplier files.
  • Support supplier audit activities as required.
  • Perform other TransMedics tasks and duties as assigned/required.
MANAGEMENT RESPONSIBILITIES
  • This position will not have management responsibilities.
PHYSICAL ATTRIBUTES
  • General Office Environment
    • May sit for extended periods of time
  • Ability to lift up to 25 pounds
  • Ability to travel is required (approximately 5 - 10%).
MINIMUM QUALIFICATIONS
  • BS in Engineering
  • 3 to 5 years of experience; experience in supplier quality preferred.
PREFERRED QUALIFICATIONS
  • Lead auditor experience (Internal and/or Supplier auditing) preferred.
  • Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 9001.
  • Practical knowledge and experience using Minitab or other statistical analysis tools.
  • Practical knowledge and understanding of various quality tools: Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
  • Understanding and application of Gage R&R and Measurement System Analysis.
  • Understanding of CAPA/SCAR and closed loop corrective action system.
  • Process validation experience including IQ/OQ/PQ.
  • Ability to communicate ideas and information clearly, effectively and concisely.
  • Highly detail oriented with strong organization and prioritization skills.
  • Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints.
  • Basic metrology knowledge.
  • Computer knowledge and experience with Microsoft Office.
  • Must be results-driven and exhibit a sense of urgency.
  • Six sigma training/certification or Certified Quality Engineer/Auditor is a plus.
Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.
Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
Maximize your potential at TransMedics, Inc.
Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

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