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Quality Manager Medical Devices / Pharmaceutical Products

Quality Manager Medical Devices / Pharmaceutical Products

Lifecell

5 - 10 years

6 - 12 Lacs

chennai

Posted:11 hours ago| Platform:

Apply

Skills Required

iso 13485 capa qms regulatory quality manager tech transfer ce marking 21 cfr 820 medical devices pharmaceutical quality assurance risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role:

Key Responsibilities:

Support multiple quality projects across development and commercialization stages
Maintain and enhance QMS in line with ISO 13485, 21 CFR Part 820, EU MDR
Review technical documentation (DHF, risk files, validation records)
Assist in regulatory submissions (510(k), CE marking)
Collaborate with cross-functional teams to embed quality throughout the product lifecycle
Lead quality activities in design transfer and process validation
Apply risk management principles per ISO 14971 and ICH Q8/Q9/Q10
Support internal/external audits, CAPA, and change control
Liaise with manufacturing partners for audit/inspection readiness

Required Skills:

Strong knowledge of ISO 13485, 21 CFR Part 820/210/211, EU MDR
Experience with regulatory documentation and submissions (510(k), CE marking)
Tech transfer or scale-up support is desirable
Excellent communication and interpersonal skills
Ability to work effectively in dynamic, team-based environments

Experience:

Education:

Preferred Industry:

Please apply here for faster responses from HR Team-

https://forms.gle/H9AcbJSXbAw65ux99

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