Sr. Documentation Specialist

Sr. Documentation Specialist

The St. Louis office is currently seeking a Sr. Documentation Specialist focusing on multiple regulatory projects for the St. Louis site, representing a global leader in medical device manufacturing, known locally for its exceptional work culture and innovative solutions.

Join a team that is shaping the future of healthcare technology. You’ll work in a collaborative, innovative environment where your documentation experience ensures the highest quality and compliance standards for life‑saving products.

As a Sr. Documentation Specialist, you will play a crucial role in ensuring compliance with company procedures and FDA Quality Systems Regulations by managing document control and interfacing with multiple departments.

You will be responsible for generating and updating essential documents such as Bill of Materials, recipes, and engineering change masters managed in our ERP system. Your role will also involve proofreading, composing, and modifying documentation to ensure accuracy and adherence to standards.

• Use change management systems and other defined processes to ensure compliance with company procedures and FDA Quality Systems Regulations.
• Generate or update Bill of Materials, recipes, and documents in Engineering Change Masters within the ERP system.
• Interface with multiple department personnel, including other sites, to ensure alignment and release of instrument change processes, BOMs, and recipes.
• Communicate with internal and external review teams to obtain necessary approvals for document release.
• Facilitate projects by assisting with organizational tasks for various engineering teams.
• Proofread documentation for accuracy and adherence to standards, consolidating and reconciling comments from production or engineering personnel.
• Compose, modify, and format assembly documentation, including instrument assembly, test procedures, and packaging drawings, according to departmental standards.

• Document control experience in a medical or regulated industry.
• Proficiency in Trackwise Digital Change Control and SAP.
• Strong proficiency in Microsoft Office Suite.
• Excellent written and oral communication skills.

• Enjoy a supportive work environment with benefits including two weeks of paid time off and ten paid holidays. Work hours and specific shift information are not specified, but the role requires interfacing with both local and international teams, necessitating strong communication and collaboration skills.

• Bachelor’s Degree in English or Technical Communication with four years of experience.
• Vocational/Technical training Certificate or Associate’s Degree with six years of relevant experience.
• Experience with technical publications, graphic design, or technical writing.
• Familiarity with Adobe InDesign, Illustrator, and Photoshop is a plus.

Enjoy benefits such as two weeks of PTO and ten paid holidays. This role requires collaboration with international teams and adherence to departmental styles and standards. The work environment encourages attention to detail and strong organizational skills.

This is a Contract position based out of St. Louis, MO.

The pay range for this position is $35.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in St. Louis, MO.

This position is anticipated to close on Feb 20, 2026.

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