SUN PHARMA
Overview
QA Medical Device Specialist II
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SUN PHARMA . This role supports 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 will help maintain and enhance the Quality Management System (QMS), ensure compliance with global regulatory requirements, and prepare the site for inspections and audits. Responsibilities
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. Qualifications
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 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 including 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 governing plans, policies, practices, agreements, or other materials in effect from time to time. If hired, the employee will be in an “at-will position.” Notice to Agencies
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.
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QA Medical Device Specialist II
at
SUN PHARMA . This role supports 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 will help maintain and enhance the Quality Management System (QMS), ensure compliance with global regulatory requirements, and prepare the site for inspections and audits. Responsibilities
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. Qualifications
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 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 including 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 governing plans, policies, practices, agreements, or other materials in effect from time to time. If hired, the employee will be in an “at-will position.” Notice to Agencies
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.
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