Technical Writer IV (Contract) Job at Blue Star Partners, LLC in Irving

Job Title : Technical Writer IV

Location : Irving, TX – 100% Onsite

Duration : 6 Months (Through 12 / 31 / 2025, with possible extension)

Rate : $45 – $50 / hr (W2)

Interview Process : 2 Rounds (Phone / Video)

Position Summary :

We are seeking a highly detail-oriented Technical Writer IV with a strong background in the medical device industry . The ideal candidate will support the creation, editing, and management of technical documentation to ensure regulatory compliance and product testing standards are met. This role will play a critical part in developing and revising SOPs, forms, and procedures for internal teams and regulatory bodies.

Key Responsibilities :

Develop, write, and maintain accurate and compliant documentation including procedures, forms, testing instructions, and regulatory materials.

Translate complex technical concepts into clear and user-friendly content for engineers, QA professionals, and technicians.

Collaborate with cross-functional teams including R&D, Quality, and Process Owners to gather and validate documentation requirements.

Ensure all documentation complies with internal standards and Good Documentation Practices (GDP) .

Manage document revisions, version control, and archival processes.

Support CAPA-related documentation and participate in usability studies and risk assessments.

Assist in the creation of internal SOPs and training materials.

Required Qualifications :

Minimum of 5+ years of technical writing experience in medical device , pharmaceutical , or FDA-regulated environments.

Proficiency with document management systems and Microsoft Office .

Strong working knowledge of medical terminology , regulatory writing standards , and FDA documentation requirements .

Excellent written and verbal communication skills.

Ability to manage multiple projects with tight deadlines.

Must have experience working in an onsite role in a regulated environment .

Preferred Experience :

Background in medical device, pharma, or other FDA-regulated industries.

Experience with CAPA documentation and training SOPs .

Familiarity with ISO 13485 and other quality management systems.

Education :

Bachelor's degree in English , Communications , Life Sciences , Engineering , or a related field.

Equivalent work experience may be considered in lieu of degree.