Scientific Technical Writer- Medical Devices- Autoimmunity
Share
Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 days ago
Vacancies:
1 Vacancy
Job Summary
Overview
Job Summary
The Scientific Technical Writer will be responsible for creating editing and maintaining high-quality documentation for Biotech IVD instrumentation and reagent projects. This includes authoring and revising CAPAs (Corrective and Preventive Actions) V&V (Verification & Validation) reports and protocols and other quality and regulatory documents. The position supports the R&D and Quality teams by ensuring all documentation meets internal standards and regulatory requirements.
Responsibilities
Key Accountabilities
- Develop edit and maintain technical documentation including CAPAs V&V reports protocols and quality documents for in-vitro diagnostic instruments.
- Collaborate with R&D Quality Manufacturing and Regulatory teams to gather information and ensure accuracy and completeness of documentation.
- Ensure all documents comply with company procedures regulatory standards and design control requirements.
- Participate in document reviews audits and updates as required.
- Support the creation and maintenance of Design History Files (DHF) and other records as needed.
- Translate complex scientific concepts into clear concise and accurate documentation for internal and external audiences.
- Communicate effectively with cross-functional teams to clarify requirements and resolve documentation issues.
Networking/Key relationships
- R&D teams: Assay Development and Biomarker discovery
- Manufacturing and Operations Teams
- Quality & Regulatory Teams
- Global Systems Support
- Software and Hardware Teams (within Werfen or external)
Qualifications
Minimum Knowledge & Experience for the position:
Bachelors in Life Sciences Engineering or related field (Masters a plus). At least 3 years technical writing experience in biotech medical device or IVD sectors.
Skills & Capabilities:
- Experience with design control processes and document control systems.
- Familiarity with V&V documentation CAPA processesand quality management systems.
- Strong attention to detail organizational and communication skills
- Proficiency with Microsoft Office (Word Excel Acrobat).
- Experience with in-vitro diagnostics or medical device documentation.
- Knowledge of regulatory standards (FDA ISO 13485 etc.).
- Ability to work independently
- Ability to manage priorities across multiple projects simultaneously.
Travel requirements:
None required.
The hourly range for this role is currently $36.00 range to $46.00 range. Individual employee compensation will ultimately depend on factors including education relevant experience skillset knowledge and particular business needs.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.
We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Since 1959, we’ve harnessed our passion to create a history of innovative specialized diagnostics breakthroughs in vitro diagnostics, improve the quality of test results, and enhance patient care.
