Senior Post Market Specialist

This position will support the mission for unsurpassed quality and reliability in our medical devices by providing technical and quality systems expertise on post market surveillance within the Post-Market Quality organization. You will serve as a subject matter expert by developing and implementing post market surveillance processes, including performing planning and reporting for products and product development projects. You will interface with various cross functional teams on post market surveillance inputs, deliverables and actions, including plans and periodic safety update reports.

Responsibilities:
This role will be part of Diabetes Post-Market Quality Organization. Individuals in this role will provide technical and quality system expertise on post market surveillance for all on-market Diabetes products and new product development projects. The ideal candidate for this position has a strong technical background and experience in medical device post market surveillance requirements, processes, planning and reporting.
Responsibilities may also include the following and other duties may be assigned.

• Develops, modifies and maintains quality system procedures/documentation in area of responsibility
• Supports internal or external audit activities, including preparation, resolution of audit and inspection findings and liaison with auditing groups and inspectors through all stages of the audits.
• Collaborates with engineering, risk management, operations, clinical, medical safety, complaint handling, data analytics and regulatory functions on post market surveillance inputs/reviews
• Lead development/review/release of post market surveillance plans/reports, including periodic safety update reports for all Diabetes products.
• Supports new product introduction activities with development of post market surveillance plans
• Develop, maintain, and execute post market surveillance reporting schedule for all Diabetes products.
• Complete updates/reporting for metrics and quality management review inputs on post market surveillance reports/deliverables.
• Review/conduct analysis of data, including field complaints/vigilance reports for post market surveillance reports
• Identify key follow up activities from post market surveillance reporting and assign/track follow up actions with the respective functions.
• Performs other related duties as assigned
• Understand complex issues and consult with various functions to conduct meaningful analyses.
• Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations
• Driving clarity and consistency in documentation
• Work directly with Enterprise/operating entities to ensure compliance to procedures, requirements and meet regulations.

Background Requirements:

• Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality or an Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
• Previous Quality experience working in medical device or related industry, specifically post market surveillance. Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, MDR, ISO 13485 and/or other relevant international standards.
• Strong oral communication, presentation, and technical writing skills
• Strong problem solving and analytical skills. Ability to review/analyze data/trending
• Ability to work effectively within team and across functions
• Must be able to handle multiple tasks/projects and manage priorities accordingly to meet deadlines.
• Knowledge of medical devices; able to understand and assess risks/benefits
• Self-Starter with a sharp focus on quality and customer experience.