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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!

Technical Writer/Change Analyst (Experienced with Medical Device Products)

The Technical Writer will provide overall management of technical writing projects, assigned to them by the Sr. Technical Writer, of clients’ needs in the areas of design, creation and maintenance of technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, etc. The Change Analyst shall provide day to day activity support for Client and/or RQMIS change control and quality records procedures assuring compliance with applicable Quality Management System (QMS), standards and regulations. 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 & Responsibilities:

Responsible for the timely completion of the following activities:

  • Organize material and finish the given material with required style, terminology, clarity and order.
  • Coordinate with Project Manager and client representatives to establish technical specifications required for publication
  • Support RQMIS/Clients in understanding and following their applicable change control process. Process Change Controls orders (DCOs, ECNs, ECOs, etc.) as defined in the relevant QMS with a goal of completeness and timeliness. Assure all change records are properly stored, maintained and archived according to the relevant QMS.
  • Maintain/Implement/Utilize any electronic tools (including cloud based) to maintain the QMS of RQMIS/Client. Examples include Matrix and Greenlight Guru.
  • Involvement in the development of product documentation
  • Develop/Publish regulatory submissions: 510(k), IDE, PMA, etc.
  • Create and edit Quality System documentation (SOPs, Flowcharts, and so on)
  • Technical file creation/maintenance
  • All documentation conversion
  • Participate in other projects as needed

Education & Professional Experience:

  • Bachelor’s degree in engineering/technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, chemist, microbiologist, etc.), or similar work experience
  • 1 to 3 years’ experience with medical device regulations/standards (including domestic and international markets)
  • Experience creating technical documentation
  • Strong attention to detail
  • Strong computer skills, including Word, Excel, SharePoint, OneDrive, Visio and Adobe Professional and cloud based change control process software.
  • Ability to communicate technical concepts to a non-technical audience
  • Excellent 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
  • Ability to uphold the stress of traveling
  • 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: No more than 10%

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

Senior Software Regulatory/Quality Systems Analyst – Medical Device and Combination Products

RQMIS, Inc. is looking for a Full Time Senior Software Regulatory/Quality Systems Analyst – Medical Device and Combination Products person.

The Senior Software Regulatory/Quality Systems Analyst – Medical Device and Combination Products will provide overall support and management of client needs in the area of software 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 process effectiveness and efficiency. In addition, senior analyst shall assure the appropriate documentation and testing is identified for regulatory submissions. Provide support for the development, management and execution of client and/or public training courses in the area of software quality system design/ management/compliance. Provide leadership to RQMIS employees in the area of project management and quality systems. Support the development/ implementation/management of tools for RQMIS employees in performing their duties.

Position Duties and Responsibilities:

  • Assist and support client’s product development activities through interpretation and implementation of FDA’s GMPs, QSR, GTPs, ISO 9001, ISO 13485, 21 CFR part 820 requirements and other regulatory/standard requirements as they apply to the development and manufacturing of software-based medical products.
  • Assure software documentation and testing satisfies IEC 62304 and IEC 82304 and will support US and EU/UK regulatory submissions.
  • 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.
  • Apply Design of Experiments (DOE) to process qualification/validation.
  • Design and implement IQ/OQ/PQ for client equipment and processes.
  • Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485, 21 CFR part 820 and other regulatory/standards 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, 21 CFR part 820, etc.
  • Assist in the development of CMC regulatory submissions for domestic and international markets

Education & Professional Experience:

    • Working knowledge of Medical Device and Combination Products
    • Bachelor’s degree in computer science/engineering/scientific field (biochemical engineer, biomedical engineer, pharmacist, chemist, biologist, microbiologist), or similar work experience
    • 6 to 10 years’ experience with drug, biologics, tissue regulations/standards (including premarket submissions for domestic and international markets)
    • Knowledge of domestic/international drug, biologics, tissue and combination product 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

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.