What are the responsibilities and job description for the Change Analyst (Experienced with Medical Products) position 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
Interested applicants, please submit your resume to employment@rqmis.com for consideration.
Are you tired of working contract to contract? We are looking for a Full Time Person!
The Change Analyst will work with our consultants/clients in supporting projects managing labeling, regulatory submissions, quality system documentation and/or clinical study material. The Change Analyst will support the governing change control process for Client and/or RQMIS. In addition, the Change Analyst will provide training to clients and internal staff.
OVERALL RESPONSIBILITIES:
The Change Analyst will provide overall management of projects, assigned to them by the Sr. Technical Writer, of clients’ needs in the areas of review/approval/control of technical documentation and records. 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/control.
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
- 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:
- Associate or Bachelor’s degree in engineering drafting, engineering tech/technical field or similar work experience
- 1-5 years’ experience in a change analyst role using eQMS systems to manage document control process
- 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 – 25%
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.
