Our client, a Global Medical Device Manufacturer has an immediate opening for a Technical Writer for a 12 Month Contract opportunity. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.
The RAQA Technical Writer will be responsible for developing, standardizing, and maintaining clear and accurate documentation including operating procedures, work instructions, and forms. This role ensures that all documentation complies with internal standards, regulatory requirements, and best practices for clarity, consistency, and usability. The Technical Writer will collaborate closely with subject matter experts (SMEs), process owners, and cross-functional teams to capture complex processes and translate them into user-friendly documentation.
Responsibilities
- Implementing quality standards and ensuring compliance at every stage of the process.
- Assessing potential risks, maintaining compliance, and providing recommendations for improvement.
- Taking responsibility for all quality control aspects of the process, including laboratory studies, clinical research, testing, operations, raw materials, production, and finished products or services.
- Facilitating audits and regulatory inspections to ensure readiness and adherence to standards.
- Coordinating quality training sessions to promote adherence to quality practices across teams.
- Developing, standardizing, and maintaining clear, accurate documentation such as operating procedures, work instructions, and forms.
- Ensuring all documentation complies with internal standards, regulatory requirements, and best practices for clarity, consistency, and usability.
- Collaborating closely with subject matter experts (SMEs), process owners, and cross-functional teams to capturing complex processes and translating them into user-friendly documentation.
Requirements
- Bachelor's degree in Engineering, Technical Communication, Life Sciences, or a related field
- 3+ years of experience in technical writing, preferably within regulated industries (e.g., medical devices, pharmaceuticals, manufacturing).
- Familiarity with Quality Management Systems (ISO 9001, ISO 13485).
- Supporting regulatory compliance efforts, including audits and inspections.
- Conducting risk assessments such as CAPAs, NCRs, and Gap Analyses.
- Contributing to M&A integration and process harmonization.
- Using document control and quality management software tools.
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iMPact Business Group, Inc.