Senior Manager, Supplier Development

At CeQur, we aim to provide solutions to people with diabetes that are profoundly simple and clinically effective. We are looking for like-minded A+ team players to join our team to help make a difference and build a legacy while driving penetration of our therapies. CeQur values a collaborative and creative mindset, where each team member is encouraged to contribute to our processes, decisions, planning and company culture.

Position Overview:

The Senior Manager, Supplier Development is a key leadership role responsible for developing, executing, and sustaining robust supplier qualification, performance management, and continuous improvement programs. This individual will partner cross-functionally with Quality, Operations, R&D, Regulatory Affairs, and external suppliers to ensure that all sourced materials and components meet CeQur’s high standards for quality, reliability, and compliance. This is a highly strategic and hands-on role, ideal for someone who excels in a fast-paced, innovative medical device environment and is passionate about building strong supplier relationships and operational excellence.

Key Responsibilities:

· Lead Supplier Qualification and Development Activities:
Develop and execute qualification plans for new suppliers, components, and materials. Collaborate with internal teams to define critical requirements and ensure robust validation protocols are met.

· Supplier Performance Management:
Create, manage, and communicate supplier scorecards and performance metrics. Lead regular supplier business reviews to address quality trends, performance gaps, and improvement opportunities.

· Nonconformance and Root Cause Investigation:
Own the process for investigating and resolving raw material/component nonconformances, ensuring timely root cause analysis and effective corrective/preventive actions (CAPAs).

· Audit and Compliance Support:
Plan and participate in supplier audits to ensure ongoing compliance with FDA 21 CFR 820, ISO 13485, and other applicable standards. Support internal and external audits as a subject matter expert on supplier quality.

· CAPA and Continuous Improvement:
Drive continuous improvement initiatives within supplier operations. Lead or support CAPAs related to supplier issues and collaborate cross-functionally to resolve recurring quality challenges.

· Cross-functional Collaboration:
Serve as the primary liaison between CeQur and its suppliers. Partner with Engineering, Operations, Quality, and Regulatory Affairs to ensure alignment of supplier capabilities with business and product needs.

· Inspection and Quality Support:
Support incoming inspection strategies by working with internal teams or external inspection services to ensure proper verification of incoming components.

Education:

• BS/BA in Engineering, Quality, or related technical field; advanced degree preferred.
• CQE and/or CQA certifications are highly desirable.

Experience and Skills:

• 10+ years of experience in a quality or supplier development role in the medical device industry.
• Strong working knowledge of FDA 21 CFR 820, ISO 13485, and relevant international regulations.
• Proven experience in supplier qualification, auditing, and quality issue resolution.
• Experience with wearable or combination medical products and their manufacturing processes (e.g., injection molding, automated assembly) is preferred.
• Deep understanding of risk management tools (e.g., FMEA, fault tree analysis).
• Strong statistical analysis and problem-solving skills.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Excellent verbal and written communication skills.
• Demonstrated ability to manage multiple priorities in a dynamic, fast-paced environment.
• Strong interpersonal skills with the ability to work cross-functionally and influence at all levels.

Requirements:

• Light lifting may be required
• Up to 25% travel

Job Type: Full-time

Pay: $130,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Greenville, SC 29601