QA Medical Device Specialist II
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 Medical Device Specialist II 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 Medical Device Specialist II
Billerica, MassachusettsJob Summary:
Responsible for assisting QA Head, Medical Device in all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Assist in ensuring 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:
Participate in all regulatory inspections related to medical device and combination products (FDA/ISO).
Ensure the Quality Management Systems (QMS) is suitable and effective.
Review Device History Records related to medical device products.
Propose and develop continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations.
Work on technical investigations relating to medical device Quality Complaints.
Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries.
Participate in vendor/ supplier change notification review.
Ensure Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL).
Review all medical device related documents as authorized and describe by procedures.
Manage electronic Quality Management System (Track Wise)
Review standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and corporate policy as required
Other duties as assigned
Education and Experience:
Bachelor’s degree in Science or related scientific fields
Familiar with medical device regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282).
BS in life science preferred or equivalent related experience
Works under limited supervision using independent judgment and exhibits strong attention to detail
Good verbal, written and interpersonal skills
Excellent understanding of medical device QA principles, industry practices, and standards
Minimum 2-4 years related experience preferably in pharmaceutical (manufacturing) environment, Quality Assurance, Quality Control and/or production, or FDA regulated industry
Working knowledge of cGMPs Standards
Experience in pharmaceutical environment (manufacturing and/or Quality)
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 preferred.
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