Education Level:Bachelor's Degree (±16 years)
Technical Writer -We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives. The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production.
Follow design control for new software product development per FDA and international guidelines
Build Design History File for new software product development
Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs
Manage document change control
Develop Standard Operating Procedures
Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
Development of customer-facing documentation e.g. user guides, training manuals
Solicit, align, and incorporate feedback from diverse stakeholders.
Education Requirements: Bachelors in related field plus 5 year of experience
Qualifications: Excellent verbal and written communication skills. Skills in Microsoft Office.Ability to work in a fast paced environment. Ability to drive project progress per assigned task.Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community. Knowledge of FDA regulations for software product development. Translates software user needs.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.