The Quality Systems or Engineering Consultant is to advise and implement quality systems for medical device manufacturers. This position requires utilization of Quality Management System methods, including but not limited to: quality system implementation, project management, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. Must interact with consultants, clients, suppliers, and experts outside QA Consulting in order to communicate and implement QA Consulting’s objectives. This is a full-time position.
Consultant shall 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, and compliance. Provide support for the development, implementation, and management of tools for RQMIS employees in performing their duties.
Consultant shall demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and options; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, postmarket surveillance and vigilance; and distribution.
Position Duties and 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 and 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.
- Supply Design of Experiments (DOE) to process qualification and validation.
- Design and implement IQ, OQ and PQ for client equipment and processes.
- Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485 and other regulatory andstandards 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
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
- Identify issues early in the submission preparation process that could impact product launch
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- 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 regulatory issues
- Communicate and negotiate with regulatory authorities and stakeholders
Education and Professional Experience:
- Bachelor’s degree in engineering or technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, microbiologist, etc.), or similar work experience
- 4 to 6 years’ experience with medical device regulations and standards (including premarket submissions for domestic and international markets)
- Knowledge of domestic and international medical device regulations, standards, and guidances
- Strong attention to detail
- Good oral and written communication skills.
- Ability to effectively manage multiple tasks while continuously assessing company and departmental priorities
Interested? Send your resume with the position of interest in the subject to firstname.lastname@example.org