Quality Consultant - Change Configuration Specialist

Job Description

RQMIS, Inc. is a fast growing, medical device/biotechnology consultancy with as focus on regulatory strategy/submissions, clinical study design/management and quality systems design/compliance/auditing. We are looking for an experienced Technical Writer for our Amesbury, MA office. This person shall work with our consultants in supporting projects involving regulatory submissions, quality system documentation and/or clinical study material. This is a wonderful opportunity for someone who enjoys a variety of projects, and working with a dynamic team of people in a thriving company.

As a Quality Consultant - Change Configuration Specialist
, you will provide overall support and management of client needs in the area of quality system design and management as well as Change Controls. 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.

As the Change Configuration Specialist
, you are responsible to design (limited to change control), support and ensure the compliance of Client’s quality system towards applicable medical devices regulations such as but not limited to ISO
13485, QSR (FDA) and the MDR/IVDR. You serve as the organizational focal point for document & records control processes to maintain the Client’s Quality Documentation through the use of the applicable documentation control system.

• 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 with 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
• Ensure that all Client and Company QMS changes are properly captured, reviewed, deployed and documented and be the Change Analyst process / administer changes and support implementation of change control processes
• Ensures requirements are implemented and reviews change to ensure compliance with configuration management procedure.
• Review /Analyzes proposed changes to determine effect on Quality Systems, manufacturing processes
• Work with Change Owners on Document and Records Controls process change implementation and ensure changes are tracked accordingly.
• Support the training of new hires and RQMIS employees on quality related topics. Create, update and develop the training material as assigned
• Works and implements special improvement assignment/projects as assigned by Direct Supervisor.

• 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/guidances.
• Strong attention to detail.
• Strong computer skills, including word processing,…