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Arthrex · 2 weeks ago

Manager, Supplier Quality (Sustaining and Development)

Naples, FL

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a Manager, Supplier Quality to develop and lead a global Supplier Quality Management program, focusing on supplier development and compliance to ensure high product quality. This role involves collaboration with various stakeholders and requires leadership of the Supplier Quality team.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

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 20%

Qualification

FDA Quality System RegulationISO 13485Supplier Quality ManagementProblem solving methodologiesSupplier development processSAPMathematical skillsLeadershipCommunication

Required

Bachelor's degree in Engineering or Science required

10 years experience in a medical device or similar regulated environment required

7 years of related supplier quality 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)

Eligible for discretionary Long Term Incentive program

Company

Arthrex

Glassdoor4.0

Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.

Founded in 1981

Naples, Florida, USA

10001+ employees

https://www.arthrex.com/

H1B Sponsorship

Arthrex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (30)

2024 (22)

2023 (13)

2022 (13)

2021 (9)

2020 (12)