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Insulet

Medical Device Complaint Team Lead

LocationGuadalajara, Jalisco
Work modehybrid
Typefull-time
DepartmentComplaint Evaluation
Company size1,001–5,000 people
First seen1w ago
Last seen15h ago
About the role
Job Summary
The GPM Complaint Evaluation Team Lead is responsible for leading the daily operations of the Complaint Evaluation team, ensuring timely and compliant complaint assessments, accurate coding, and reportability determinations. This role combines technical expertise in complaint handling with operational leadership, overseeing workload planning, team performance, quality compliance, and process improvements. The Team Lead provides coaching and guidance to team members, manages escalations and complex complaint cases, monitors key performance metrics, and collaborates with cross-functional stakeholders to support regulatory compliance, audit readiness, and continuous improvement initiatives. Success in this role requires strong leadership, analytical thinking, organizational skills, and the ability to drive performance in a fast-paced, highly regulated medical device environment.
The GPM Complaint Evaluation Team Lead serves as the operational leader for the Complaint Evaluation team, responsible for driving operational execution, workload prioritization, quality compliance, and team performance while maintaining technical expertise in complaint evaluation, coding, and reportability determination. The role provides day-to-day leadership, coaching, and guidance to team members to ensure compliance with regulatory requirements, achievement of departmental objectives, and continuous improvement of processes. The Team Lead serves as the primary point of escalation for operational challenges and is accountable for supporting the achievement of team productivity, quality, and service level goals.
Responsibilities:
• Lead day-to-day operations of the Complaint Evaluation team, ensuring timely completion of complaint assessments and compliance with applicable procedures.
• Coordinate workload distribution, resource planning, and prioritization to meet operational and regulatory deadlines.
• Assess team capacity, forecast workload demands, and recommend resource adjustments to support business needs.
• Accountable for supporting the achievement of team performance objectives, including productivity, quality, service level, backlog management, and due date compliance metrics.
• Monitor team performance metrics, identify risks and trends, and implement actions to achieve operational goals.
• Provide coaching, mentoring, training, and technical guidance to team members to support professional development and process compliance.
• Lead performance discussions and support employee development plans.
• Perform complaint evaluations, coding, and reportability determinations for complex, high-risk, or escalated cases as required.
• Conduct quality reviews to ensure compliance with quality system requirements and complaint handling procedures.
• Monitor quality trends, identify systemic issues, and implement corrective and preventive actions to improve performance and compliance.
• Identify, communicate, and escalate operational risks, resource constraints, compliance concerns, and business impacts to management.
• Support root cause investigations, CAPA activities, effectiveness checks, and implementation of corrective and preventive actions.
• Support FDA, ISO, internal, and external audits, ensuring audit readiness and timely response to audit observations.
• Serve as the primary operational liaison between the Complaint Evaluation team and cross-functional stakeholders.
• Collaborate with Quality, Regulatory Affairs, Vigilance, Product Support, Customer Care, and other functional groups to resolve complex complaint handling issues.
• Lead and participate in Continuous Improvement initiatives that enhance quality, compliance, and operational efficiency.
• Support special projects and other duties as assigned.
Education and Experience/ Minimum Requirements:
• Bachelor’s degree in Life Sciences, Engineering, or a related field required; or an equivalent combination of education, training, and relevant professional experience.
• 3-5 years Complaint evaluation/processing experience
• Minimum of 1-2 years’ experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.
• Demonstrated subject matter expertise in complaint evaluation, coding, and regulatory reporting processes.
• Proven experience in data management, record keeping, and troubleshooting within the Medical Device industry or related regulated environments.
• Proven ability to lead, coach, mentor, and develop team members while driving accountability and performance.
• Strong verbal, written, technical writing, and interpersonal communication skills.
• Demonstrated ability to organize, prioritize, and manage multiple competing priorities with minimal supervision.
• Strong attention to detail and commitment to quality and compliance.
• Proven ability to achieve operational goals and objectives within a team environment.
• Critical thinking, problem-solving, adaptability, and sound decision-making skills.
Preferred Skills and Competencies:
• Previous experience in a formal or informal leadership role.
• Ability to influence stakeholders and drive alignment across cross-functional teams.
• Experience providing performance feedback and supporting employee development plans.
• Proven ability to foster accountability, engagement, and continuous improvement within a team environment.
• Ability to make timely decisions using available information while identifying when escalation or additional guidance is required.
• Experience supporting audits, inspections, CAPAs, and quality system compliance activities.
• Willingness to pursue additional learning and professional development opportunities.
• Strong organizational, analytical, and risk assessment skills.
• Ability to manage conflict and navigate complex situations in a fast-paced regulated environment.
About the company
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
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