What are the responsibilities and job description for the Medical Device Compliance Specialist position at Suru?
As a Quality Assurance Manager at Suru, you will play a critical role in ensuring the quality and safety of our medical devices. We are seeking an experienced professional with a strong background in quality management, cleanroom operations, and regulatory affairs. The ideal candidate will have excellent leadership skills, a proven track record of success in quality management, and a deep understanding of regulatory requirements.
The successful Quality Assurance Manager will be responsible for leading quality assurance activities, managing cleanroom operations, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 regulations. They will also develop and implement quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
Key qualifications for this role include:
• 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).
The successful Quality Assurance Manager will be responsible for leading quality assurance activities, managing cleanroom operations, and ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 regulations. They will also develop and implement quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
Key qualifications for this role include:
• 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).
