What are the responsibilities and job description for the Quality Manager position at Harba Solutions Inc.?
Responsibilities
- Oversee all aspects of the sites quality function, ensuring compliance with ISO 13485 and FDA Part 820 regulations.
- Act as the sites Management Representative and lead the Quality team.
- Monitor and enhance the Quality Management System (QMS), ensuring regulatory and industry compliance.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Oversee internal, supplier, and customer audits, ensuring timely resolution of corrective actions.
- Implement and maintain quality control measures, including process validations, risk management, and documentation control.
Qualifications
The Company
Our organization is a global leader in providing high-quality containment solutions, drug delivery systems, and analytical services for the pharmaceutical and biotech industries. We are driven by science, leveraging advanced manufacturing technologies, automation, and regulatory expertise to bring innovation to life. Our commitment to quality and precision ensures that we stay ahead in a rapidly evolving industry.
