Quality Specialist

Roles & Responsibilities:

1. Quality Oversight

• Supervise and implement quality control measures across manufacturing operations to ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards.
• Conduct regular in-process and final inspections of products to identify defects and ensure they meet specifications.

2. Manufacturing Process Monitoring

• Collaborate with manufacturing teams to monitor and control production processes, ensuring adherence to Good Manufacturing Practices (GMP).
• Review and approve manufacturing process documentation, including SOPs, work instructions, and validation protocols.

3. Quality Systems Management

• Maintain and support the quality management system (QMS), including corrective action and preventive action (CAPA), non-conformance, and complaint handling.
• Conduct root cause analyses and drive effective CAPAs for product and process non-conformances.

4. Risk Management

• Participate in risk management activities, such as Failure Mode and Effects Analysis (FMEA), to assess and mitigate risks related to manufacturing processes.
• Support the creation of risk management files in compliance with ISO 14971 standards.

5. Documentation and Reporting

• Prepare, review, and maintain quality documentation, including batch records, inspection records, and test reports.
• Ensure accurate and timely reporting of quality metrics, and present findings to management.

6. Internal and External Audits

• Participate in internal audits to ensure compliance with regulatory and quality standards.
• Support external audits by regulatory agencies, notified bodies, and customers as needed.

7. Continuous Improvement

• Identify opportunities for improvement within the manufacturing process and participate in continuous improvement initiatives.
• Collaborate with cross-functional teams, including engineering, R&D, and production, to enhance product quality and operational efficiency.

8. Training

• Provide training and guidance to production staff on quality control and manufacturing best practices.

Preferred candidate profile