Sr. Supplier Quality Engineer, B2B Customer Liaison (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

54d•Hybrid

About The Position

This role plays a strategic part in strengthening Insulet's reputation for quality and reliability, ensuring customer satisfaction and fostering long-term partnerships. As a critical interface between Insulet's B2B customers and internal quality teams, this role ensures that all customer feedback is managed in alignment with our Quality Management System (QMS) and that a closed loop process is well executed. The successful candidate will play a major role in defining and executing complaint handling, corrective actions, and regulatory documentation processes between Insulet and these external entities—reinforcing our commitment to safety, compliance, and continuous improvement in the medical device industry.

Requirements

Strong understanding of QMS systems, complaint handling, and regulatory frameworks.
Exceptional organizational skills and attention to detail.
Excellent written and verbal communication abilities.
Professional handling of confidential and sensitive information.
Proficiency in analyzing quality data and generating actionable insights through dashboards or reports.
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.
Demonstrates agility and responsiveness to evolving B2B customer needs and quality challenges.
Effectively influences cross-functional teams and B2B partners to drive resolution and improvements.
Demonstrates a strong customer-centric mindset, advocating for B2B customer needs.
Builds strong cross-functional partnerships across Engineering, Operations, and Account Management.
Communicates clearly, concisely, and persuasively across all organizational levels.
Possess exceptional skill in handling competing priorities and requirements, especially with external entities.
Adept at driving consensus and action, culminating in clear communication.

Responsibilities

Act as the primary Quality contact between Insulet and external B2B customers.
Ensure appropriate intake, investigation, documentation, and escalation of B2B customer complaints, nonconformances, deviations, and product quality feedback.
Actively manage and resolve B2B customer escalations related to product quality, ensuring timely and effective communication and resolution.
Collaborate cross-functionally with B2B Customer Project Teams, Quality Assurance, Regulatory Affairs, Supplier Quality, and Engineering to resolve product issues.
Coordinate B2B customer approvals for design and manufacturing changes impacting devices.
Review and evaluate change notifications, ensuring timely support to B2B customer impact assessments and alignment with quality and regulatory requirements.
Contribute to risk assessments and mitigation strategies for B2B customer-facing quality issues and product changes.
Drive timely follow-up and closure of B2B customer-related CAPAs by working with global manufacturing sites, internal teams, and external suppliers.
Maintain complaint files in compliance with internal procedures and external regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
Support internal and external audits with accurate records and summaries of complaint handling activities.
Lead or support internal projects involving B2B customer-specific devices.
Capture and integrate Voice of Customer insights into quality processes and product lifecycle improvements.
Develop and maintain processes for B2B customer-impacted change management and investigations.
Analyze complaint data to identify trends and contribute to quality improvement initiatives.
Support the development and maintenance of quality agreements with B2B customers ensuring alignment with regulatory and business requirements.
Ensure all communications adhere to company policies, regulatory standards, and ethical practices.
Schedule, prep, and lead periodic Quality reviews with B2B customers.
Other duties as assigned.