Sun Pharmaceutical Industries, Inc.
Senior Manager, Quality Assurance - Medical Device
Sun Pharmaceutical Industries, Inc., Billerica, Massachusetts, us, 01821
Title: Senior Manager, Quality Assurance - Medical Device
Date: May 18, 2024Company: Sun Pharmaceutical Industries, Inc (USA)Job SummaryResponsible 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 established 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 Sun Corporate Audits.Area Of ResponsibilityAs “Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO).Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective.Approve Device History Records related to medical device products.Continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.Directly handle technical investigations relating to medical device Quality Complaints.Provide verbal and written responses/resolutions to customers regarding product quality complaints or product inquiries.Oversight of the vendor/supplier management program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.In all vendor/supplier change notification review and approvals.Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL).Approve all medical device related documents as authorized and described by procedures.Electronic Quality Management System (Track Wise).Standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guidelines and corporate policy as required.Other duties as assigned.Work Conditions:OfficeManufacturing FloorWarehouseThird Party site (as required)Physical Requirements:Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance.Talk or hear.Close and clear vision.Computer/office machines.Lift up to 10 lbs.Some travel outside of company facility as required.Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses).Education and Job QualificationBachelor’s degree in Science or related scientific fields.Strong knowledge of medical device 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 to multi-task and manage competing 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.ExperienceMinimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.Strong knowledge of medical device regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).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 medical device-related complaints.Knowledge of vendor/supplier management program.Working knowledge of Trackwise to handle electronic Quality Management 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.
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Date: May 18, 2024Company: Sun Pharmaceutical Industries, Inc (USA)Job SummaryResponsible 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 established 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 Sun Corporate Audits.Area Of ResponsibilityAs “Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO).Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective.Approve Device History Records related to medical device products.Continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.Directly handle technical investigations relating to medical device Quality Complaints.Provide verbal and written responses/resolutions to customers regarding product quality complaints or product inquiries.Oversight of the vendor/supplier management program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier.In all vendor/supplier change notification review and approvals.Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL).Approve all medical device related documents as authorized and described by procedures.Electronic Quality Management System (Track Wise).Standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guidelines and corporate policy as required.Other duties as assigned.Work Conditions:OfficeManufacturing FloorWarehouseThird Party site (as required)Physical Requirements:Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance.Talk or hear.Close and clear vision.Computer/office machines.Lift up to 10 lbs.Some travel outside of company facility as required.Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses).Education and Job QualificationBachelor’s degree in Science or related scientific fields.Strong knowledge of medical device 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 to multi-task and manage competing 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.ExperienceMinimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.Strong knowledge of medical device regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).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 medical device-related complaints.Knowledge of vendor/supplier management program.Working knowledge of Trackwise to handle electronic Quality Management 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.
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