QA Medical Device Specialist II

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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
  Track Wise
  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 Track Wise
  ,
  EDMS
  ,
  LMS
  , and preferably
  SAP
  or
  Master Control
  .
• 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.

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…