QA Supervisor

Position Summary

The Supervisor will oversee daily quality related tasks at manufacturing floor. This role involves ensuring compliance with industry regulations, written procedures and work instruction, finding out noncompliance at shop floor and in cross functional team activities and to highlight/resolve them following appropriate procedures. This role required to manage quality inspectors at shop floor who are testing product quality with respect to written specification. This role is responsible to ensure high quality products are being manufactured by ensuring all in-process quality related checks performed at specified intervals. This role also required to review and ensuring completeness of all manufacturing batch records prior to release of finished products in market. The Supervisor will collaborate with other departments to drive continuous improvement.

Principal Responsibilities

1. Team Leadership:
   - Supervise and mentor a team of quality inspectors at shop floor.
   - Conduct regular performance evaluations and provide constructive feedback.
   - Foster a collaborative and positive work environment.

2. Operational Oversight:
   - Monitor daily quality operations at shop floor to ensure efficiency and compliance with     SOPs/Work     Instructions
   - Coordinate work schedules, assign tasks, and manage workflow to meet targets.
   - Troubleshoot and resolve quality related issues promptly.
- Having good data analysis skills and able to manage/ prioritize tasks

3. Quality Assurance:
   - Ensure all activities comply with industry standards and regulatory requirements 
(e.g., FDA,     ISO 13485).
   - Implement and maintain quality control processes to uphold product standards.
   - Conduct regular audits and inspections.

4. Continuous Improvement:
   - Identify opportunities for process improvement and implement best practices.
   - Participate in cross-functional teams to develop and implement improvement projects.
   - Monitor and report on key performance indicators (KPIs).

5. Compliance and Documentation:
   - Ensure accurate and timely documentation of processes, procedures, and incidents.
   - Maintain up-to-date knowledge of regulatory requirements and industry trends.

6. Collaboration:
   - Work closely with others to align on organizational goals.
   - Facilitate effective communication within the team and across the organization.
   - Represent the department in meetings and project discussions wherever required
 

Education / Experience Requirements

- Bachelor’s degree in engineering, Life Sciences, or a related field.
- Minimum of 2-3 years of experience in the medical device or related industries
- Strong knowledge of USFDA regulations, ISO 13485, and GMP standards.
- Proven ability to lead and develop a high-performing team
- Good problem-solving, organizational, and communication skills.
- Proficiency in relevant software and tools (MS Office), SAP shall be additional benefit
 

Specialized Skills / Other Requirements