Quality Systems Consultant
Provide overall support and management of client needs in the area of quality system design and management. This support shall assure that the client will achieve compliance with specified objective(s) in terms of regulations and standards conformance, as well as, operational process effectiveness and efficiency. Provide support for the development, management and execution of client and/or public training courses in the area of quality system design/ management/compliance. Provide support for the development/implementation/ management of tools for RQMIS employees in performing their duties.
POSITION DUTIES & RESPONSIBILITIES:
• Assist and support client's product development activities through interpretation and implementation of FDA's QSR, GTPs, ISO 9001, ISO 13485 requirements and other regulatory/standard requirements.
• Assist in developing and maintaining client's quality system procedures, CAPA process, inspection instructions, and related documentation in support of product development, production and post market activities.
• Apply Design of Experiments (DOE) to process qualification/validation.
• Design and implement IQ/OQ/PQ for client equipment and processes.
• Audit client's quality system to assure compliance to the FDA's QSR, ISO 13485 and other regulatory/standards requirements.
• Develop and implement tools for RQMIS employees in conducting their activities
• Develop and execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements such as FDA's QSR, GTPs, ISO 13485, ISO14971, etc.
• Assist in the development of regulatory submissions for domestic and international markets
EDUCATION & PROFESSIONAL EXPERIENCE:
• Bachelor's degree in engineering/technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, microbiologist, etc.), or similar work experience
RQMIS Inc. is a solutions-driven provider of therapeutically focused, comprehensive regulatory consultation to the global medical device, combination product and human tissue industry. The regulatory consultancy is focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate the FDA and EU regulations. We are headquartered just outside of Boston, MA.
Sat, 23 Sep 2017 11:20:38 PDT