Technical Writer
Location : Portage, MI
Hours/Schedule : Mon- Fri 8am- 5pm
Type: Contract
Overview
Global Medical Device company looking to hire experienced Technical Writer to join their team. The Technical Writer will be responsible for developing, standardizing, and maintaining clear and accurate documentation including operating procedures, work instructions, and forms.
Key Responsibilities
- Develop, write, edit, and maintain operating procedures, work instructions, and forms in alignment with company policies, industry standards, and regulatory requirements.
- Ensure that all documentation complies with internal standards, regulatory requirements, and best practices for clarity, consistency, and usability.
- Partner with subject matter experts (SMEs) and process owners to gather information and ensure accuracy of technical content.
- Standardize documentation format and ensure consistency across departments.
- Review, update, and manage document revisions to reflect process improvements or regulatory changes.
- Ensure documentation complies with applicable quality management system (QMS) requirements (e.g., ISO 9001, ISO 13485, FDA, or other relevant standards).
- Create documentation that is clear, concise, and easily understood by intended users, including technical and non-technical audiences.
- Support audits and inspections by providing controlled, accurate documentation.
- Collaborate with training teams to align documentation with employee training and onboarding programs.
- Maintain document control within approved systems and ensure proper version management.
- Develop process flows that clearly illustrate the end-to-end solution.
- Bachelor’s degree in Engineering, Technical Communication, English, Engineering, Life Sciences, or a related field, or equivalent experience.
- 3+ years of experience in technical writing, preferably within regulated industries (e.g., medical devices, pharmaceuticals, manufacturing).
- Strong knowledge of operating procedures, work instructions, and controlled forms.
- Familiarity with Quality Management Systems (ISO 9001, ISO 13485) and regulatory requirements preferred.
- Excellent written and verbal communication skills with a strong attention to detail.
- Ability to translate complex technical concepts into clear, concise documentation.
- Proficiency in Microsoft Office Suite and document management systems (e.g., SharePoint, MasterControl, or similar).
- Strong organizational and project management skills, with the ability to manage multiple priorities.
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref: #558-Scientific
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