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Experience level: Mid Level (5-8 yrs exp.) Experience required: 5 Years Education level: Bachelors degree Job function: Quality Assurance Industry: Biotechnology Compensation: $81,000 - $100,000 Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No
END CLIENT NAME: Associates, Inc., a biotechnology manufacturing company.
SUMMARY: The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services.
RESPONSIBILITIES:
Oversee the company's adherence to domestic and international regulatory standards, including FDA regulations, ISO standards, ASTM, and European Medical Device Regulation, for medical device design and development.
Lead the development, implementation, and maintenance of the Quality Management System (QMS) and quality procedures, aligning them with operational changes and reporting quality and regulatory issues to leadership.
Manage product conformity, including the evaluation of nonconforming products, and lead corrective actions for QMS audits, ensuring no repeat non-conformances from audits.
Provide strategic regulatory guidance, oversee risk management, validation, and conformity activities, and lead the transition to and management of an electronic QMS system.
Coordinate external audits, FDA Inspections, and conduct Management Reviews to ensure QMS effectiveness, serving as the company's main regulatory liaison for FDA correspondence, registrations, and device listings.
Offer regulatory advice and support to the company and its subsidiaries, ensuring staff compliance with regulatory affairs and quality management practices, and maintain up-to-date knowledge of regulatory requirements in the US, EU, and other regions.
Engage in global standards organizations' committee work, demonstrate proficiency in relevant technologies, and function within an FDA, CGMP, and ISO environment, with periodic travel primarily within the United States and other duties as assigned.
BENEFITS:
Health Insurance (medical, dental, vision)
401K with match
PTO, Paid Holidays
Bonuses
ST & LT Disability
Pet-friendly
ESR Healthcare
