Medical Device Complaint Team Lead (Medical Devices)

Location: Guadalajara, Jalisco, Mexico

Company

hirify.global develops the Omnipod wearable, waterproof medical device platform to support simpler and healthier lives for customers.

What you will do

• Lead daily operations of the Complaint Evaluation team, including workload distribution, prioritization, capacity planning, and backlog management.
• Monitor productivity, quality, service-level, and due-date compliance metrics; identify risks and implement corrective actions.
• Perform evaluations, coding, and reportability determinations for complex, high-risk, and escalated complaints.
• Provide coaching, mentoring, training, technical guidance, and performance support to team members.
• Conduct quality reviews and support root-cause investigations, CAPA activities, effectiveness checks, and corrective actions.
• Collaborate with Quality, Regulatory Affairs, Vigilance, Product Support, Customer Care, and other stakeholders on audits, escalations, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, or an equivalent combination of education, training, and relevant experience.
• 3–5 years of complaint evaluation or processing experience.
• 1–2 years of experience in data management, record keeping, and troubleshooting in the medical device field or a related regulated environment.
• Subject matter expertise in complaint evaluation, coding, and regulatory reporting processes.
• Experience leading, coaching, mentoring, and developing team members while driving accountability and performance.
• Strong communication, technical writing, organizational, analytical, problem-solving, risk assessment, and decision-making skills.

Nice to have

• Formal or informal leadership experience.
• Experience supporting audits, inspections, CAPAs, and quality system compliance activities.
• Experience influencing stakeholders, managing conflict, and driving alignment across cross-functional teams.
• Experience providing performance feedback and supporting employee development plans.

Culture & Benefits

• Work in a fast-paced, highly regulated medical device environment.
• Contribute to products designed to improve patients’ everyday lives.
• Participate in professional development and continuous improvement initiatives.
• Collaborate with cross-functional teams focused on quality, compliance, and customer outcomes.