Manager, Supplier Quality (Sustaining and Development)

Arthrex•Pelican Bay, FL

About The Position

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 Manager, Supplier Quality (Sustaining and Development) for our Global Headquarters in Naples, FL. The Supplier Quality Manager will develop, implement and lead a consolidated global Sustaining and Development (S&D) Supplier Quality Management program including supplier development, approval, validation, certification, change control and corrective actions to drive a high level of product quality and compliance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.

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%.