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!

Clinical Database Manager

The Clinical Trials Project Manager will develop, implement and manage all aspects of clinical trials in domestic and international countries for our clients. In addition, the Clinical Trials Project Manager will provide training to clients and internal staff. This is a full-time position.

Overall Responsibilities:

  • Responsible for all data management tasks from study start-up through database lock. This includes database design, development of data management documents, and development of CRFs/eCRFs.
  • Meet internal and external (Sponsor) deadlines and requirements according to time, quality, scope, and budget parameters.
  • Ensures all data is accurate by programming edit checks, data cleaning, and generating and managing queries.
  • Provide training support to clients and study staff on Electronic Data Capture (EDC) usage.
  • Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
  • Support the team with ongoing project work, as determined by business need
  • Experience in project management roles, particularly in clinical data management, operations or project leadership role
  • Up to 10% travel may be required.

Data Management

  • Develop and/or review case report forms (CRFs) within EDC system.
  • Author SOPs and WIs related to data management activities and the needs of the client, including the Data Management Plan, Data Transfer Plan, and Data Validation Plan.
  • Lead all data cleaning activities, including data review and query generation and management.
  • Aid in SAE reconciliation and reconciliation of external data (e.g. Core Lab).
  • Ensure all medical coding is performed in a timely manner.
  • Lead all database lock activities.

EDC Management

  • Maintain close working relationship with software vendor.
  • Build study database, program queries and edit checks.
  • Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues.
  • Provide training support to clients and study staff on EDC usage.

Data Reporting and Analysis

  • Produce study status reports, data tables, listings, or other outputs as required throughout the course of the project.
  • Work with the Biostatistician in development of the Statistical Analysis Plan.

Education & Professional Experience:

  • Bachelor’s Degree or higher in a related field, such as clinical/science fields
  • Three (+) years of professional experience in clinical data management best practices, managing, cleaning and integrating large, complex databases and in health information systems and informatics standards
  • 3 – 5 years’ experience in Health Data Analysis/Management, Statistics, FDA regulation clinical studies, and/or Public Health (Epidemiology/Biostatistics Focus) a plus.
  • Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
  • Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Strong working technical skills, including Microsoft Office, EDC platforms, and programming languages. Ability to learn new applications.

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

Quality System or Engineering Consultant

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.

OVERALL RESPONSIBILITIES:

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, post-market surveillance and vigilance; and distribution.

POSITION DUTIES & 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 and 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, 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 post-marketing 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 employment@rqmis.com

Technical Writer

The Technical Writer will work with our consultants/clients in supporting projects involving regulatory submissions, quality system documentation and/or clinical study material. In addition, the Technical Writer will provide training to clients and internal staff.

Overall Responsibilities:

Design, create and maintain technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, and so on.

Position Duties and Responsibilities:

Responsible for the timely completion of the following activities:

  • Organize and publish material with required style, terminology, clarity and order
  • Coordinate with Project Manager and client representatives to establish technical specifications required for publication
  • 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
  • 0 – 1 years (current college students 3rd. yr. – 4th. yr. are encouraged to apply)
  • 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 promoting for all job classifications is done without regard to any of the characteristics mentioned above, except when a bonafide occupational qualification exist. 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, the way we do business at RQMIS, and is an important principle of sound business management.