Manager, Supplier Quality – Sustaining and Development
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • United States
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About the role
- 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
supplier quality managementrisk based supplier corrective action processsupplier audit processroot cause analysissupplier performance metricsproblem solving methodologiesFDA Quality System RegulationISO 13485Six Sigma8D
Soft Skills
leadershipcoachingmentoringcommunicationproblem definitiondata analysiscritical thinkingcollaborationreportingstakeholder engagement