Work Location: St. Louis, Missouri Shift: No Department: LS-SC-PMLQD Cell Marque Quality Recruiter: Ashley Hennessy
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma, as the Technical Document Reviewer, you have responsibility for reviewing technical documents related to invitro diagnostic (IVD) products, ensuring accuracy, compliance with regulatory standards, and alignment with internal quality guidelines. The role will involve assessing content, structure, and clarity of product documentation, ensuring they meet both internal and external requirements.
Key Responsibilities:
Review technical documentation, including product manuals, instructions for use, product specifications, risk management files, regulatory submissions and other related documents to ensure accuracy, clarity and compliance with regulatory requirements, including ISO 13485, IVDR, and other applicable standards.
Assess the quality of documents, ensuring they are well-structured, free of errors, consistent in terminology, and aligned with internal style guides and templates.
Collaborate with team members to ensure documents accurately reflect product functionality, design and regulatory requirements.
Verify the accuracy of technical content and ensure consistency across all documents, including terminology, format and style.
Manage version control and ensure that the most current documents are being reviewed and approved. Maintain an organized system for tracking document revisions and updates.
Provide detailed feedback to document authors regarding document structure and content clarity. Suggest edits, revisions or additions to improve document quality.
Participate in customer and regulatory audits, as a Subject Matter Expert of applicable Quality Management System(s)
Who You Are:
Minimum Qualifications:
Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, etc.) or a technical discipline (e.g., Computer Science, Data Science, etc. )
1+ years experience in reviewing technical documentation
Preferred Qualifications:
Experience in reviewing technical documentation within the medical device, healthcare, or pharmaceutical industry.
Familiarity with regulatory requirements for medical device documentation
Attention to detail and strong analytical skills
Proficiency in reviewing technical content for clarity, accuracy, and compliance with internal guidelines and industry standards
Highly developed interpersonal, written, and verbal communication skills
Ability to work autonomously, effectively manage time and deliver results on time
Strong organizational skills and ability to handle multiple projects simultaneously in a fast paced environment
Ability to work collaboratively in cross-functional teams and manager stakeholder expectations
RSREMD
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.