Technical Writer with Change Controls

4 weeks ago

Amesbury, United States RQMIS Full time

**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**:
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

**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.**:

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