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.

OVERALL RESPONSIBILITIES:

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 ISO13485, 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.

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 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.

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/guidances.
• 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.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment, and interact/observe operations on a manufacturing floor.

· Specific vision abilities required by this job include close vision requirements due to computer work and observing manufacturing processes.

· Light to moderate lifting is required.

· Regular, predictable attendance is required; including quarter-driven hours as business demands dictate.

The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Moderate noise (i.e., manufacturing environment, business office with computers, phone, and printers, light traffic).

· Ability to work in a confined area.

· Ability to sit at a computer terminal for an extended period of time.

TRAVEL:

Less than 25%