Senior Quality Specialist

Our On-Demand Talent Solutions group is happy to announce that we are hiring a Senior Quality Specialist with our client whose culture is rooted in a shared mission to improve lives through innovative diabetes care. We are looking for employees who are ready to take the next step in their career and who enjoy working in a purpose-driven environment that continues to evolve and improve.

The Senior Quality Specialist plays a part in strengthening quality, reliability, ensuring customer satisfaction, and fostering long-term partnerships. This critical role ensures that all customer feedback is managed in alignment with our Quality Management System (QMS) and that closed loop processes are well executed.

• Act as the primary quality contact for external B2B customers, ensuring appropriate intake, investigation, documentation, escalation, and resolution of B2B customer complaints, nonconformances, deviations, product quality feedback and escalations.
• Collaborate cross-functionally with B2B Customer Project Teams, Quality Assurance, Regulatory Affairs, Supplier Quality, engineering, global manufacturing sites, to resolve product issues in a timely manner.
• Maintain complaint files in compliance with internal procedures and external regulations (ISO 13485, FDA 21 CFR Part 820) and support audits aligned with company policies.
• Drive timely follow-up and closure of B2B customer-related CAPAs by partnering with global manufacturing sites, internal teams, and external suppliers.
• Capture and integrate Voice of Customer insights into quality processes, product lifecycle, and continuous quality improvements.
• Develop and maintain B2B customer–impacted change management, investigations, quality agreements, and lead periodic quality reviews.

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of 5 years of experience in medical device customer service or quality support.