Quality Manager - Senior

Job Title: Quality Manager (ISO 13485 – Medical Devices)

Location: M46, Sultanpur(V),Telangana
Experience: 5+ years in Medical Device Quality Management
Industry: Medical Devices
Employment Type: Full-time
Salary: Based on interview performance

Key Responsibilities:

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations.
• Develop, implement, and maintain the Quality Management System (QMS).
• Lead internal and external quality audits and manage audit findings and CAPA processes.
• Monitor and analyze non-conformances, deviations, and implement corrective/preventive actions.
• Supervise document control, change control, and record retention activities.
• Review and approve validation protocols and reports (process, equipment, software).
• Coordinate with cross-functional teams for quality assurance during design, manufacturing, and distribution phases.
• Ensure supplier quality management, including audits and evaluations.
• Conduct training programs on quality system procedures and regulatory requirements.
• Manage management review meetings and ensure timely updates to leadership.
• Maintain records for complaints, returns, and adverse events as per regulatory standards.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• Minimum 5 years of experience in medical device quality assurance.
• Strong knowledge of ISO 13485, QSR (21 CFR 820), and risk management per ISO 14971.
• Experience in leading audits (e.g., Notified Body, FDA).
• Proficient in CAPA, Root Cause Analysis, and FMEA.
• Excellent communication, leadership, and problem-solving skills.

Preferred Certifications (not mandatory):

• Certified Quality Auditor (CQA)
• Lead Auditor – ISO 13485

Job Type: Permanent

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Yearly bonus

Work Location: In person