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 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 Drug GMPs (21CFR211), Device GMPs (QSR 21CFR820), GTPs, ISO 13485 and ISO14971 requirements and other regulatory/standard requirements.
- Assist in developing and maintaining client’s quality system procedures, inspection instructions, and related documentation in support of product development, production and post market activities.
- Audit client’s quality system to assure compliance to the FDA’s GMPs, ISO 13485 and other regulatory/standards requirements.
- Develop and implement tools for RQMIS employees in conducting their activities.
- Develop/execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements.
- Assist in the development of manufacturing sections of regulatory submissions for domestic and international markets.
- Design and implement IQ/OQ/PQ for client equipment and processes.
- Ensure compliance with product postmarketing approval requirements
- Provide regulatory input for and appropriate follow-up to inspections and audits
- Identify product-associated problems and develop proposals for solutions
- Problem-solve with and advise clients on quality issues
- Communicate and negotiate with regulatory authorities and stakeholders
EDUCATION & PROFESSIONAL EXPERIENCE:
- Bachelor’s degree in engineering/technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, chemist, microbiologist, etc.), or similar work experience.
- 4 to 6 years’ experience with medical device regulations/standards (including for domestic and international markets).
- Knowledge of domestic/international medical device regulations/standards/guidance’s.
- Strong attention to detail.
- Strong computer skills, including word processing, spreadsheet and data programs.
- Good oral and written communication skills.
- Good leadership skills.
- Ability to effectively manage multiple tasks while continuously assessing company and/or departmental priorities.
No more than 25%