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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in documentation management within the medical device industry, including the preparation and editing of quality system compliant documentation. Proficient in maintaining compliance with regulatory standards such as ISO 13485 and FDA QSMR while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
Documentation ManagementQuality System ComplianceISO 13485 FamiliarityFDA QSMR KnowledgeMolecular Biology Understanding
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Documentation PreparationTechnical Document EditingBatch Record TrackingVersion ControlSOP DraftingQuality System DocumentationRegulatory Submission FamiliarityIVD Clinical Validation SupportLab Process DocumentationInformation Management
Soft Skills
OrganizedDetail OrientedExcellent Written SkillsExcellent Verbal SkillsTeam Driven
Tools & Technologies
QMS SystemsDocumentation Filing Systems
Industry Keywords
Medical Device IndustryIVDLDTLife SciencesMolecular Biology Techniques
About the role
Key responsibilities & impact- Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
- Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
- Track batch records and checklists produced during IVD clinical validations and ensure compliance
- Maintain appropriate filing systems
- Review documentation for consistency and compliance
- Help oversee implementation of new documentation and version control
- Serve as a point of contact for documentation retrieval
- Aid in preparation for internal and external audits
- Manage multiple sources of information for documentation purposes
- Continuously improve IVD and LDT development documentation and processes
- Work closely with Technical and Development Scientists, technologists, Quality, and Regulatory professionals
Requirements
What you’ll need- Bachelor’s degree plus 2+ years of documentation experience in the medical device industry
- Organized and detail oriented
- Excellent written and verbal skills
- Ability to work well with cross functional teams
- Team driven
- Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques highly desirable
- Ability to thrive in a fast paced environment highly desirable
- Familiarity with a range of QMS systems and regulatory submissions highly desirable
- Familiarity with ISO 13485 and FDA QSMR highly desirable
Benefits
Comp & perks- Incentive compensation may be offered
- Restricted stock units may be offered
- Medical and other benefits depending on the position