Job Description

Responsibilities

• Oversee all aspects of the site’s quality function, ensuring compliance with ISO 13485 and FDA Part 820 regulations.
• Act as the site’s 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

• A Bachelor’s degree in Engineering or a related field, with 5-10 years of experience in quality management within a manufacturing environment, preferably in medical devices.
• Plastic injection molding experience, required.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and quality assurance principles.
• Experience in process controls, validations, and quality risk management.
• Excellent communication and leadership skills with the ability to influence stakeholders.
• Hands-on experience in metrology, calibration standards, and statistical methods for manufacturing.
• Certification as a Quality Manager or Quality Engineer is a plus.

The Company

Our organization is a global leader in providing high-quality containment solutions 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.

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