Title: QA Medical Device Specialist II

Date: Sep 11, 2025

Location: Sun - Billerica - Plant

Company: Sun Pharmaceutical Industries, Inc (USA)

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

As a QA Medical Device Specialist II, you will support the QA Head in ensuring that all medical devices and combination products—whether manufactured in-house or by third-party partners—meet rigorous quality standards. You’ll play a key role in maintaining and enhancing our Quality Management System (QMS), ensuring compliance with global regulatory requirements, and preparing the site for inspections and audits.

Area of Responsibility:

Participate in FDA, ISO, and other regulatory inspections related to medical devices and combination products.
Ensure the QMS is compliant, effective, and aligned with corporate and regulatory standards.
Review Device History Records (DHRs) and ensure documentation accuracy.
Lead and support continuous improvement initiatives for QMS processes.
Investigate and resolve quality complaints and provide timely responses to customers.
Review and assess vendor/supplier change notifications and maintain the Approved Supplier List (ASL).
Oversee annual supplier assessments, audit schedules, and vendor status tracking.
Manage and maintain documentation within TrackWise and other electronic systems.
Review and update SOPs to ensure alignment with FDA, ISO, EU MDR, and CMDR regulations.
Support internal audits and ensure site readiness for corporate and regulatory inspections.
Mentor junior team members and contribute to cross-functional collaboration.
Perform other duties as assigned.

Education and Experience:

Bachelor’s degree in Life Sciences or a related field.
2–4 years of experience in a medical device or pharmaceutical manufacturing environment.
Strong working knowledge of:
- FDA regulations: 21 CFR Part 4, 210/211, 820
- International standards: ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282)
Experience with TrackWise, EDMS, LMS, and preferably SAP or MasterControl.
Familiarity with radiopharmaceutical manufacturing and testing is a plus.
Excellent verbal, written, and interpersonal communication skills.
Strong attention to detail and ability to work independently.
Proficient in MS Office and electronic quality systems.

Why Sun Pharma?

At Sun Pharma, you’ll be part of a mission-driven organization that values quality, innovation, and collaboration. We offer a dynamic work environment, opportunities for professional growth, and the chance to make a meaningful impact in the medical device and pharmaceutical industries.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.