Onsite Manager, Supplier Quality – Sustaining and Development

Posted 4 hours ago

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About the role

  • Manager of Supplier Quality at global medical device company Arthrex overseeing supplier quality management programs. Leading quality compliance and development efforts with a focus on product integrity and supplier partnerships.

Responsibilities

  • Develop a vision/strategy and sustain / implement a global S&D Supplier Quality Management organization and related systems/processes in collaboration with Supply Chain and Operations.
  • Develop, monitor, and report status of related goals to upper Management.
  • Provide leadership and direction to the S&D Supplier Quality team to proactively work in partnership with suppliers and internal stakeholders to improve product/process quality and compliance.
  • Ensure that product design specifications/requirements are effectively understood by suppliers and related manufacturing processes are verified/validated to confirm conformance.
  • Maintain an effective supplier audit process focusing on manufacturing process, testing, quality process best practices and compliance to relevant standards.
  • Develop, manage and maintain a supplier development process to ensure suppliers meets all applicable design and quality/compliance requirements as well as acceptable scores.
  • Coordinate nonconformance and CAPA activities with suppliers while developing strong root cause capabilities.
  • Implement, manage and maintain a risk based supplier corrective action process.
  • Develop, maintain and report supplier performance metrics/scorecard, and drive improvement actions for under-performers.
  • Develop, implement, and maintain a supplier certification program to reduce/eliminate redundant in-house inspections.
  • Coordinate related system/process improvements with all relative stakeholders.
  • Coach and mentor the Supplier Quality team members.
  • This role requires travel up to 50%.

Requirements

  • Bachelor’s degree required preferably in an Engineering or Science discipline
  • 10 years experience in a medical device or similar regulated environment required
  • 7 years of related supplier quality management experience required
  • 3 years of supervisory experience required
  • Strong working knowledge of FDA Quality System Regulation, ISO 13485 and problem solving methodologies such as 8D, 5 Whys, Six Sigma, etc.
  • Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to verbally communicate ideas and issues effectively to other team members and management.
  • Ability to write and record data and information as required by procedures.

Benefits

  • 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 Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

Job title

Manager, Supplier Quality – Sustaining and Development

Job type

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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