Purpose of Position/Essential Duties:
- Explain technical ideas in simple language
- Own end-to-end documentation creation process
- Work closely with internal teams to deeply understand product and documentation requirements
- Write, edit, and review design control and risk management documents that meet Quality Management System standards
- Write, rewrite and/or edit technical documents such as technical procedure manuals, user manuals, programming manuals, service manuals, operational specifications, and related technical publications to communicate clearly and effectively technical specifications and instructions to a wide range of audiences.
- Create manufacturing documentation for a variety of products and processes, including work Instructions, SOPs, flow charts and other work aids.
- Meet and collaborate with scientists, quality, product management, and manufacturing to define and establish operational procedures and manuals for operational activities and tasks.
- Write clearly and concisely to meet the needs of the target audience.
- Prepare process flows, specifications, mockups.
- Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements.
- Work with minimal supervision and manage time effectively.
- Bachelor’s Degree in a science related field and 5+ years of technical writing experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
- Experience with ISO 9001, ISO 13485, and/or GMP environments.
- Strong understanding of Design Control and Change Control.
- Experience in writing scientific papers is preferred.
- Excellent written and verbal communication skills.
- Proficiency in MS Office.
- Experience working in the regulated medical device industry.
Knowledge, Skills, Abilities:
- Strong attention to detail and high regards for quality.
- Able to write in explanatory and procedural styles for multiple end users.
- Skilled at prioritization and multi-tasking in a self-driven, performance/results oriented, fast paced matrixed environment.
- Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment.
- Understanding of FDA and international regulations, requirements, and guidances related to submissions, reporting, and document preparation
- Ability to quickly translate complex processes \into easily understood writing, diagrams, and technical illustrations
Job Type: Full-time
Pay: From $36,000.00 per year
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off