General Manager Quality Assurance

Concept Medical Inc.; Surat; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Concept Medical Inc. is seeking a leader for their Quality Assurance function to ensure compliance with global regulatory standards and maintain an effective Quality Management System (QMS). The ideal candidate will drive continuous improvement and ensure product quality and patient safety.

Key responsibilities include managing QMS compliance, overseeing audits and inspections, handling CAPA, and validating processes. A Bachelor's or Master's degree in relevant fields is required.

Qualifications

• Bachelor's or master's degree required.
• Relevant experience in Quality Assurance functions.
• Strong understanding of regulatory standards.

Responsibilities

• Lead and maintain QMS compliance as per ISO 13485, FDA QSR, EU MDR.
• Handle internal, supplier, customer, and regulatory audits.
• Manage CAPA, deviations, and risk management activities.
• Oversee validation activities for various processes.
• Approve SOPs and quality documents.

Skills

Leadership Skills

Decision Making

Cross-functional Coordination

Regulatory Communication

Crisis Management

Team Leadership

Education

Bachelor's/Master's degree in pharmacy, Life Sciences, Biomedical Engineering, Biotechnology, or related

Job description

To lead the Quality Assurance function by ensuring compliance with global regulatory standards, maintaining an effective QMS, driving continuous improvement, and ensuring product quality and patient safety.

Key Responsibilities

• Lead and maintain QMS compliance as per ISO 13485, FDA QSR, EU MDR, MDSAP, and GMP.
• Handle internal, supplier, customer, and regulatory audits/inspections.
• Manage CAPA, deviations, root cause investigations, and risk management activities.
• Oversee validation activities including IQ/OQ/PQ, process, cleaning, software, and equipment validation.
• Approve SOPs, quality documents, validation reports, and product release activities.
• Ensure supplier qualification, complaint handling, and nonconformance management.
• Monitor quality metrics such as rejection, NCR, yield, and rework trends.
• Lead QA team development, training, and performance management.
• Coordinate with cross-functional teams and Regulatory Affairs for compliance and audit readiness.

Technical Skills

• Leadership Skills
• Decision Making, Cross-functional Coordination, Regulatory Communication, Crisis Management, Team Leadership.

Qualification

Bachelors/master’s degree in pharmacy, Life Sciences, Biomedical Engineering, Biotechnology, or related