What are the responsibilities and job description for the Quality Assurance Director position at Suru?
About Suru
Suru is a mid-size medical device manufacturer based in New Jersey. We are committed to producing high-quality medical tubing and filling needles while adhering to strict regulatory standards.
Job Description
We are seeking a Quality Assurance Manager to oversee our cleanroom facility and ensure compliance with quality standards. The successful candidate will lead quality assurance activities, manage cleanroom operations, and maintain compliance with ISO 13485 and FDA 21 CFR Part 820 regulations.
Main Responsibilities
• Oversee and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards.
• Develop, implement, and maintain quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
• Lead internal and external audits, including audits from regulatory agencies and customers.
• Manage non-conformances, corrective and preventive actions (CAPA), and customer complaints.
Key Skills and Qualifications
• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related field.
• Minimum of 5-7 years of experience in medical device manufacturing, with at least 3 years of experience in a cleanroom environment.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Experience managing cleanroom operations in a regulated manufacturing environment.
• Demonstrated experience with CAPA, root cause analysis, non-conformance management, and process validation (IQ/OQ/PQ).
Suru is a mid-size medical device manufacturer based in New Jersey. We are committed to producing high-quality medical tubing and filling needles while adhering to strict regulatory standards.
Job Description
We are seeking a Quality Assurance Manager to oversee our cleanroom facility and ensure compliance with quality standards. The successful candidate will lead quality assurance activities, manage cleanroom operations, and maintain compliance with ISO 13485 and FDA 21 CFR Part 820 regulations.
Main Responsibilities
• Oversee and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards.
• Develop, implement, and maintain quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
• Lead internal and external audits, including audits from regulatory agencies and customers.
• Manage non-conformances, corrective and preventive actions (CAPA), and customer complaints.
Key Skills and Qualifications
• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related field.
• Minimum of 5-7 years of experience in medical device manufacturing, with at least 3 years of experience in a cleanroom environment.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
• Experience managing cleanroom operations in a regulated manufacturing environment.
• Demonstrated experience with CAPA, root cause analysis, non-conformance management, and process validation (IQ/OQ/PQ).
