Leads the development, enhancement, implementation and monitoring of the Elevated Complaint Investigations (ECI) and Data Analytics team for Illumina products, complaint management of on-market regulated medical devices/IVDs, cross-functional collaboration with Customer and Field Service and Regulatory Affairs teams. The candidate is accountable and responsible for leading a team of complaint analysts, and data analysts to enhance reporting capabilities and dashboards, preparing EQRB data for executive management, as well as providing guidance on Dx requirements to the Post-Market Surveillance team. Facilitate cross functional discussions in identifying, documenting, analyzing and reporting ECIs, potential adverse events & recalls, and ensuring appropriate customer feedback evaluation.
Responsibilities: Subject matter expert (SME) and point of contact for Quality Complaint Team activities. Define, develop and maintain company procedures and processes for ECI handling and processing. Analyze complaint data, gather additional data as needed, and partner cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolve complaints. Ensure Regulatory report needs are maintained and timelines met (from ECI and Complaint Files perspective) Oversee, manage and provide input and feedback for Post Market Surveillance activities. Ensure ECI investigations are robust & defendable. Provide input and feedback to Customer Solutions (CS) complaint activities. Provide direction, training, support and implementation of Quality initiatives for the department. Develop and implement departmental process and cost efficiencies. Actively participate on Quality teams and cross-functional project teams as needed Facilitate the evaluation of ECIs, including assessment, investigation, containment, review, approval and determination of on-going needs Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs) Provide support in the reporting and execution of field actions Provide management with status updates on assigned responsibilities and goals and timely escalation of issues Prepares Executive Quality Review Board (EQRB) presentations and coordinates data collection/analysis Actively support defense of notified body audits Other activities as assigned
Ability to multi-task in a fast-paced environment and manage changing priorities
Excellent communication and people leadership skills
Ability to implement strategic policies & analytical skills
Ability to establishes and assure adherence to budgets, schedules, work plans, and performance requirements
Experience: Minimum 10 years' experience in the medical device, IVD and/or pharmaceutical industry with direct experience supporting development and commercial quality systems in a Quality Assurance role. Experience with regulatory agencies and inspections. Working knowledge in US and OUS quality systems and regulatory expectations required. Experienced management of direct reports and department responsibilities Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, IVDD & IVDR
BS degree or combination of education and experience in medical device, IVD and/or pharmaceutical industry.
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Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality