Quality Assurance Technical Writer
3 days ago
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OnsiteFull-timeSenior
Summary
Werfen North America is seeking a Quality Assurance Technical Writer to join their team in Warren, NJ. The role involves creating, revising, and reviewing product technical documentation to ensure compliance with regulatory requirements.
About the Role
As a Quality Assurance Technical Writer, you will be responsible for creating and reviewing technical documentation related to product design, validation, and regulatory submissions. You will ensure that all documentation meets quality and regulatory requirements, support global regulatory submissions, and collaborate with cross-functional teams to maintain compliance with various international medical device regulations.
About You
Required:
- Bachelor's degree in a science-related field (e.g., biology, biomedical, molecular biology).
- Five (5) or more years of experience in quality assurance in the pharmaceutical or medical device industry.
- Three (3) years of experience in technical writing.
Preferred:
- Experience with IVDR technical documentation.
- Experience creating/revising documentation in alignment with global medical device regulations: 21 CFR Part 820, ISO 13485, MDR/IVDR (2017/745 and 2017/46).
- Experience using MasterControl.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional development and growth.
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.1 billion in 2023, and our workforce is more than 7,000 strong.
Warren, NJ