System One
Head of QA, Medical Device
System One, Billerica, Massachusetts, us, 01821
Title: Head of QA Medical Device
Location: Billerica, MA (can provide relocation assistance)Duration: Direct Hire
Overview:
Our pharmaceutical client is seeking a QA professional to be responsible for all aspects of QA for Medical Device and combination products manufactured either on-site or at third-party contract manufacturers. This individual will ensure all medical devices manufactured meet established specifications and ensure site readiness for regulatory agency inspections and/or Corporate Audits.
Requirements:
Bachelor’s degree in Science or related scientific fieldsStrong 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 abilityDemonstrated understanding and deployment of modern root cause and problem-solving techniques such as statistical process controls and quality function deploymentExcellent understanding of medical device QA principles, industry practices, and standardsDemonstrated ability to multi-task and manage competing prioritiesDemonstrated strong ability in problem solvingSuperior internal and external customer service/people skillsAbility to manage multiple responsibilities and projects in a fast-paced environment, while performing in an efficient mannerAbility to work both independently and collaboratively in a team structureExcellent verbal and written communication skills, including the ability to influence othersExcellent organizational and time management skills with a high level of attention to detailMinimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environmentExperience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, corporate audits, and third-party auditsStrong knowledge of reviewing and approving device history records related to medical devicesStrong knowledge of handling medical device-related complaintsKnowledge of vendor/supplier management ProgramWorking knowledge of Trackwise to handle electronic Quality Management System (eQMS) data, EDMS for SOPs, and LMS for trainingsStrong working knowledge of MS Office softwarePreferably knowledge to handle SAP, EDMS, LMS, Master Control, etc.
Responsibilities:
Ensure all medical devices manufactured meet established specificationsEnsure compliance with established Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485, Canadian Medical Devices Regulations (CMDR SOR/98-282), and EU Medical Device Regulation 2017/745Responsible as Management Representative, leading all regulatory inspections related to medical device and combination products (FDA/ISO)Lead Management Review meetings ensuring the Quality Management Systems (QMS) are suitable and effectiveReview and approve Device History Records related to medical device productsOversight and continuous improvement and compliance of Quality Management Systems (QMS) following FDA and ISO regulationsWork directly on technical investigations relating to medical device Quality ComplaintsProvide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiriesProvide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendors/suppliersParticipate in all vendor/supplier change notification reviews and approvalsEnsure 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 described by proceduresManage electronic Quality Management System (Trackwise)Author/revise standard operating procedures (SOPs) related to medical devices and associated systems aligning with regulatory guidelines and corporate policy as requiredOther duties as assigned
Benefits:
Our client provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in their expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, they offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For them, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
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Location: Billerica, MA (can provide relocation assistance)Duration: Direct Hire
Overview:
Our pharmaceutical client is seeking a QA professional to be responsible for all aspects of QA for Medical Device and combination products manufactured either on-site or at third-party contract manufacturers. This individual will ensure all medical devices manufactured meet established specifications and ensure site readiness for regulatory agency inspections and/or Corporate Audits.
Requirements:
Bachelor’s degree in Science or related scientific fieldsStrong 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 abilityDemonstrated understanding and deployment of modern root cause and problem-solving techniques such as statistical process controls and quality function deploymentExcellent understanding of medical device QA principles, industry practices, and standardsDemonstrated ability to multi-task and manage competing prioritiesDemonstrated strong ability in problem solvingSuperior internal and external customer service/people skillsAbility to manage multiple responsibilities and projects in a fast-paced environment, while performing in an efficient mannerAbility to work both independently and collaboratively in a team structureExcellent verbal and written communication skills, including the ability to influence othersExcellent organizational and time management skills with a high level of attention to detailMinimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environmentExperience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, corporate audits, and third-party auditsStrong knowledge of reviewing and approving device history records related to medical devicesStrong knowledge of handling medical device-related complaintsKnowledge of vendor/supplier management ProgramWorking knowledge of Trackwise to handle electronic Quality Management System (eQMS) data, EDMS for SOPs, and LMS for trainingsStrong working knowledge of MS Office softwarePreferably knowledge to handle SAP, EDMS, LMS, Master Control, etc.
Responsibilities:
Ensure all medical devices manufactured meet established specificationsEnsure compliance with established Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485, Canadian Medical Devices Regulations (CMDR SOR/98-282), and EU Medical Device Regulation 2017/745Responsible as Management Representative, leading all regulatory inspections related to medical device and combination products (FDA/ISO)Lead Management Review meetings ensuring the Quality Management Systems (QMS) are suitable and effectiveReview and approve Device History Records related to medical device productsOversight and continuous improvement and compliance of Quality Management Systems (QMS) following FDA and ISO regulationsWork directly on technical investigations relating to medical device Quality ComplaintsProvide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiriesProvide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendors/suppliersParticipate in all vendor/supplier change notification reviews and approvalsEnsure 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 described by proceduresManage electronic Quality Management System (Trackwise)Author/revise standard operating procedures (SOPs) related to medical devices and associated systems aligning with regulatory guidelines and corporate policy as requiredOther duties as assigned
Benefits:
Our client provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in their expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, they offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For them, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
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