Senior Manager, Medical Device QA

• Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications.
• Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745.
• Ensure site readiness for regulatory agency inspections and/or firm Corporate Audits.
• Responsible as "Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO).
• Lead Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective.
• Review and approve Device History Records related to medical device products.
• Oversite and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.
• Work directly on technical investigations relating to medical device Quality Complaints.
• Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries.
• Provide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.
• Participate in all vendor/ supplier change notification review and approvals.
• Ensure Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL).
• Review and approve all medical device related documents as authorized and describe by procedures.
• Manage electronic Quality Management System (Track Wise)
• Author/revise standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and corporate policy as required
• Other duties as assigned

• Bachelor's degree in Science or related scientific fields
• Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.
• Strong knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).
• Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability.
• Demonstrated understanding and deployment of modern root cause and problem solving techniques such as statistical process controls and quality function deployment.
• Excellent understanding of medical device QA principles, industry practices, and standards
• Demonstrated ability of multi-task and manage completing priorities.
• Demonstrated strong ability in problem solving
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner.
• Ability to work both independently and collaboratively in team structure.
• Excellent verbal and written communication skills, including ability to influence others.
• Excellent organizational and time management skills with a high level of attention to detail.
• Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, corporate audits and third party audits.
• Strong knowledge of review and approve device history records related to medical devices.
• Strong knowledge of handling of medical device related complaints.
• Knowledge of vendor/supplier management Program
• Working knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data, EDMS for SOPs and LMS for trainings.
• Strong working knowledge of MS Office software.
• Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc...

• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.

Software Guidance & Assistance