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Job Description

The Document Manager is responsible for developing, organizing, and maintaining controlled documentation across Operations, Quality, and Engineering functions. This includes Standard Practices (SP), Standard Operating Procedures (SOP), and Standard Operating Controls (SOC) to ensure compliance with regulatory requirements and internal quality standards for a medical device manufacturer.

Key Responsibilities

• Document Development & Maintenance

• Create, review, and update SPs, SOPs, SOCs, and other controlled documents.

• Ensure documents meet regulatory standards (FDA, ISO 13485) and internal quality requirements.

• Compliance & Governance

• Maintain document control systems in alignment with Good Documentation Practices (GDP).

• Support audits by providing accurate and current documentation.

• Collaboration

• Work closely with Operations, Quality Assurance, and Engineering teams to capture technical processes accurately.

• Facilitate document reviews and approvals through established workflows.

• Training & Support

• Train staff on document control processes and ensure adherence to documentation policies.

• Continuous Improvement

Identify opportunities to streamline documentation processes and improve efficiency.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor’s degree in Engineering, Quality Management, or related field.

• 5+ years of experience in document control or technical writing within a regulated industry (medical devices preferred).

• Strong knowledge of FDA regulations, ISO standards, and GDP.

• Proficiency in document management systems (e.g., IQMS MasterControl, Veeva).

• 2+ years of experience with IQMS strongly preferred

• Excellent attention to detail and organizational skills. - Experience leading tech transfer from one GMP/ISO regulated site to another

- Experience with change control processes.

- Familiarity with risk management and CAPA documentation.

- Strong communication skills for cross-functional collaboration.