Director of Complaints, Determination

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

Position Overview
The Site Director of QA/RA is accountable for ensuring Insulet's Post Market Surveillance (PMS) system is effectively applied and that processes and practices are maintained in full compliance with all regional laws and regulations at our Mexico location. This role will also serve as the primary QA/RA point of contact for the Guadalajara, MX location.

The role encompasses general global product monitoring leadership for the Guadalajara location. This includes drafting and maintaining procedures and documents, owning the plan for the activities performed at the location and execution to ensure the office remains compliant with applicable policies, procedures, regulations, and standards. This also involves establishing a close working relationship with in-country and global Customer Care, Product Support, Region/Market Authorized Representatives, and other cross-functional internal stakeholders.

The position requires system and organization level comprehension and collaboration with constant global interaction within the business to support achieving the company goals.

This experienced people leader will manage a team of nearly 70 people and provide direction to individuals, and their supervisors, who determine and evaluate product complaints. They may provide either front room or back room support during inspections by regulatory authorities (such as competent authorities and notified bodies). Where needed, the incumbent will also lead corrective and preventive actions (CAPA) and other process improvements and provide support or leadership to global expansion efforts.

Responsibilities

• Oversee complaint intake, determination, and evaluation in compliance with FDA, Health Canada, EU MDR, and other applicable Quality System Regulations, as well as country-specific vigilance regulations.
• Serve a strong mentor, people manager, and leader. Ensure the selection, orientation, development, and retention of qualified staff to carry out the responsibilities of the department. Conduct performance appraisals and ensure development opportunities for staff.
• Manage the timely in-flow of customer complaints, determination of reportability, and, as applicable, the assignment of responsibilities, and expedient closure.
• Utilize reports/dashboards to manage productivity of the workforce and identify potential delays, bottlenecks or other indicators of backlog.
• Identify process improvement opportunities to ensure compliance, increase efficiency, and enhance surveillance. Drive process improvements where needed and lead or support CAPAs where necessary.
• Develop and maintain strong relationships with internal and external stakeholders to ensure a consistent process while identifying improvements to drive efficiency and compliance.
• Represent the QA/RA group at cross-functional meetings at the Guadalajara location.
• Ensure personnel training is completed by established due dates. Maintain training requirements for staff, including job descriptions/position requirements.
• Identify, manage, and escalate quality issues as necessary.
• Work closely with internal and external stakeholders to help drive the initiation of process nonconformance reports (GPMEs), CAPAs and SCARs when appropriate
• Maintain awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market surveillance.
• Develop and maintain product knowledge of existing and new products.
• Perform other duties as required.

Education And Experience
Minimum Requirements:

• BS/BA degree with at least 12+ years' experience with at least 8years supervisory/people management experience in the medical devices or life sciences industry with at least 4 years specifically related to post-market vigilance/surveillance and/or complaint management/handling in the medical device industry.
• Excellent communication skills (listening, verbal, and written). Demonstrated interpersonal and management skills and must be fluent in English.
• Able to exercise judgment against the criteria of applicable regulations and standards.
• Demonstrated ability to implement and maintain accurate documentation consistent with applicable quality standards.
• Strong assessment, analytical, problem-solving, and applied critical thinking skills, including trend and statistical analysis. Strong working knowledge of the development, application, and measurement of quality performance metrics. Ability to acquire, query and analyze data with focus on detail.
• Must be an independent motivated self-starter, able to motivate others, and demonstrate a high level of reliability, integrity, and personal accountability.
• Ability to effectively manage time and multiple task assignments, as well as manage team assignments and provide timely direction. Proven ability to consistently meet and/or exceed goals. Capable of making commitments, setting priorities, and delivering results on time and on budget.
• Demonstrated computer /system skills with proficiency in Microsoft Office applications., skills in internet searches and data utilization and using cloud-based complaint handling and vigilance reporting software.
• Strong leadership skills to engage, coach, and develop the team, inspire high quality and timely work, and instill a spirit of continuous improvement.
• Experience managing supervisors or team leaders in addition to individual contributors.
• Experience managing individuals across different locations and cultures.
• Demonstrated ability to use quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
• Working knowledge of global complaint handling regulations and standards.

Preferred Skills & Competencies

• Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485 & 14971, EU MDR, CMDR, and other global regulations, standards, and guidelines (such as MDSAP, IMDRF, MDCG, MEDDEV).
• Demonstrated technical writing skills are strongly preferred.
• ASQ CQE/CSQE/CQA/CMQOE, RAPS RAC, or equivalent QA/RA certification and/or lean or six sigma GB or BB or other process improvement/excellence certification.

Physical Requirements- General office environment; may sit or stand and use computer for long periods of time.
Domestic or international travel may be required on occasion (- Performs other duties as required