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QA Post Market Manager
Published on: Mar 6, 2025
Job Category: Quality
Employment type: Regular Full Time
Job Scope
The QA Post Market Manager is responsible to:
* Oversee all activities related to the complaint handling process from QA standpoint
* Manage the post market surveillance activities to ensure that medical devices continue to be safe and well-performing and to ensure corrective actions are undertaken when necessary
* Collect and evaluate experience gained from medical devices that have been placed on the market and to identify the need to take any action or to highlight opportunities to improve.
Key Duties and Responsibilities
* Managing the Post-Market Surveillance process and related deliverables to ensure compliance with all applicable internal and external requirements
* Ensuring timely and accurate processing for PMS data collection, plans and periodic reporting
* Organizing PMS team, to plan and gather all the information needed for the creation of PMS reports and Plans
* Overseeing the generation of Post-Market Surveillance plans during the product development.
* Maintaining up-to-date knowledge on global regulatory requirements for PMS, vigilance and reporting
* Ensuring the communication of PMS result to product SME, PD, production, customer care and Top Management
* Representing the PMS activities as a subject matter expert in support of internal and external audits
* Overseeing Complaint processing in compliance with FDA, Health Canada, EU, China and other country specific vigilance regulations
* Managing Field Corrective Action Activities and Adverse Event reporting to ensure compliance
* Provides and verifies the application of the Quality Management System ensuring the adequacy and updating of Quality System with respect to the regulatory and quality requirements
* Consistently striving to improve quality according to the highest standards
* Cooperating with other function to ensure that the process and procedures are in compliance with quality standard (ISO and GMP)
* providing training and spread the knowledge of the Quality System at all company levels
* Performing internal and external audit
* Collaborating with technical groups to identify product improvement opportunities
* Collaborating in the definition of the correct risk assessment on the product/process.
Education, Experience, and Qualifications
* Degree in scientific disciplines
* Knowledge of regulatory / compliance requirements applicable to in vitro diagnostics / medical devices
* At least five years of Medical Device / -IVD or chemical-pharmaceutical industry experience in similar position
* Use of Office pack
* Project Management
* Risk management and related tools
* Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, provides and verifies that the Quality Management System meets the requirements of ISO9001, ISO13485, US FDA QS Regulation (21CFR820) and the Medical Device Regulation (SOR I 98-282) of Canada
* Strong analytical skills including trend and statistical analysis Project Management.
* Strong verbal and written communication skills
* Solid problem solving and analytical skills
* Marked ability to identify risks associated with a product/process issue
* Solid interpersonal skills, including ability to negotiate and influence without authority
* Ability to supervise team members or to work as part of a team
* Ability to manage complex projects and multiple projects (5+) simultaneously
* Strong communication and interpersonal skills with ability to work well in a high-pressure environment
* Strong competency in Customer Focus and Driving for Results
* Fluent knowledge of the English language
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