QA Head, Medical Device
Billerica, Massachusetts
- Full Time
- Level: Entry
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Overview
You’re the one who will help us meet and exceed the quality standards that medical professionals and patients expect from us. Collaborating with like-minded, inventive colleagues, you’ll take a balanced approach, tackling challenges, learning from mistakes, and creating solutions that empower our fast-growing company. Join a workplace that’s big on open communication and fueling your career growth. When can you start?
Success Profile
What makes a great QA Head, Medical Device at Sun Pharma? Take a look and see how you match up.
- Collaborative
- Communicator
- Detail-oriented
- Independent
- Problem-solver
- Team player
Our Culture
Discover an environment that’s open and transparent. Every day is a new opportunity to learn and grow, surrounded by powerful reminders of the impact your role has on patients’ lives. This is the Sun Pharma way of life. And we can’t wait for you to be a part of it.
Benefits
We’re in your corner – in so many different ways. Sun Pharma wants you to have the benefits, support, and rewards of a job well done.
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Career Growth
Get support for your career growth and development.
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Benefits Programs
Discover comprehensive benefits to support the health and wellness of you and your family.
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Time Off
Enjoy paid time off and leave-of-absence options.
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Compensation
Earn competitive compensation with incentive programs that reward our shared success.
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Working Conditions
Work confidently in the safe, clean, and regulated work environment that we foster.
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Team Environment
Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.
QA Head, Medical Device
Billerica, MassachusettsJob Summary:
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 Sun Corporate Audits.
Area of Responsibility:
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
Work Conditions:
Office
Manufacturing Floor
Warehouse
Third Party site (as required)
Education and Job Qualifications:
Bachelor’s degree in Science or related scientific fields
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.
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).
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.
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