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RQMIS

Join our RQMIS team

Career Opportunities at RQMIS

Our Mission

RQMIS’ mission is to bring about safe and effective medical devices and biotechnology products by assisting companies in navigating the regulatory process and addressing governmental requirements using the most efficient and effective processes during the premarket and post-market product phases. We provide all of our employees with equal opportunities for advancement, good working conditions, while paying competitive wages.

Opportunities

RQMIS offers a comprehensive benefits package to the people who work for and support the mission of RQMIS Inc. In an effort to provide exceptional customer service to all our clients, we are seeking qualified individuals who fit the specifications detailed in the open positions below.
Interested applicants, please submit your resume to employment@rqmis.com for consideration. If you're interested in working for the company but do not see an applicable position listed below, please send us your resume as we are always looking for great candidates to join our team!

Quality Consultant – Change Configuration Specialist

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.

TRAVEL:

No more than 25%


Technical Writer with Change Controls (Experienced with Medical Device Products)

The Technical Writer will provide overall management of technical writing projects of clients’ needs in the areas of design, create and maintain of technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, change controls support and so on. Provide training to clients and internal staff on technical writing, good documentation practices and use of Microsoft and Adobe programs in document production.

Position Duties and Responsibilities:

Responsible for the timely completion of the following activities:

  • Organize and publish material with the required style, terminology, clarity, and order
  • Coordinate with Project Manager and client representatives to establish technical specifications required for publication
  • Work with Change Owners on Document and Records Controls process change implementation and ensure changes are tracked accordingly
  • Develop product documentation
  • Develop regulatory submissions: 510(k), IDE, PMA, and so on
  • Create and edit Quality System documentation (SOPs, Flowcharts, and so on)
  • Create and maintain Technical Files
  • Convert documentation as necessary
  • Participate in other projects as needed
  • Perform other duties as assigned

Education & Professional Experience:

  • Bachelor’s Degree or in the process of attaining such a degree
  • 1 to 3 years’ experience with medical device regulations/standards (including domestic and international markets)
  • Strong computer skills, including Word, Excel, Visio, and Adobe Professional
  • Excellent oral and written communication skills
  • Experience creating technical documentation
  • Ability to communicate technical concepts to a non-technical audience
  • Ability to manage several tasks simultaneously

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com

Equal Opportunity

RQMIS provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or other protected classes or characteristics protected by applicable law. Equal employment opportunity applies to all terms and conditions of employment including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.
RQMIS expressly prohibits any form of unlawful employee harassment or discrimination based on any of the characteristics mentioned above. Improper interference with the ability of other employees to perform their expected job duties is absolutely not tolerated.

RQMIS will provide equal opportunities in employment, promotion, wages, benefits, and all other privileges, terms, and conditions of employment. All recruiting, hiring, training, and promotion for all job classifications are done without regard to any of the characteristics mentioned above, except when a bonafide occupational qualification exists. All decisions on employment are made to further the principle of equal employment. All promotion decisions will continue to be made in accordance with Equal Employment Opportunity principles and only valid job requirements will be used.

Americans with Disabilities Act (ADA) and Reasonable Accommodation

To ensure equal employment opportunities to qualified individuals with a disability, RQMIS will make reasonable accommodations for the known disability of an otherwise qualified individual unless undue hardship on the operation of the business would result.

Commitment to Diversity

RQMIS is committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives. This commitment is embodied in company policy, and the way we do business at RQMIS, and is an important principle of sound business management.