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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in document control processes and quality management systems, ensuring compliance with ISO standards, FDA regulations, and other regulatory requirements. Proficient in using electronic document management systems and managing documentation activities in a fast-paced, regulated environment.
Highest-signal resume keywords
Document Control ProcessesQuality Management SystemsISO Standards ComplianceElectronic Document Management SystemsRegulatory Requirements Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Document ControlQuality SystemsRecords ManagementRegulatory ComplianceDocumentation AuditsDatabase ApplicationsReport GenerationProcedural Changes ImplementationContinuous Improvement InitiativesDocument Accuracy Maintenance
Soft Skills
Cross-Functional CollaborationCommunication SkillsTime ManagementProblem-SolvingIndependence
Tools & Technologies
Microsoft OfficeElectronic Document Management SystemsDatabase Applications
Industry Keywords
ISOFDAOSHAMedical DevicesPharmaceuticalsHealthcareManufacturingQuality Systems
About the role
Key responsibilities & impact- Establish, update, and manage documentation controls for supplier quality
- Maintain, update, and distribute policies, procedures, supplier quality records, and other controlled documents through electronic document management systems
- Conduct document audits and monitor records for compliance with internal requirements and external regulations and standards, including ISO, FDA, and OSHA
- Help maintain documentation readiness for audits and inspections
- Verify documentation completeness and accuracy prior to release
- Incorporate approved changes into databases
- Generate standard and custom reports
- Partner with quality, engineering, manufacturing, and operations teams to resolve documentation discrepancies
- Implement procedural changes and maintain training documentation
- Support continuous improvement initiatives
Requirements
What you’ll need- High School Diploma/GED or higher (completed and verified prior to start)
- Two (2) years of combined experience in document control, quality systems, coordination support, or records management
- Associate's degree or higher in Business, Quality, Engineering, Life Sciences, or a related discipline (additional qualification)
- Experience working in a regulated environment, such as medical devices, pharmaceuticals, healthcare, manufacturing, or quality systems
- Experience applying document control processes and quality management system requirements
- Experience applying ISO standards, FDA regulations, or other regulatory requirements
- Experience using electronic document management systems (EDMS), database applications, and document control systems
- Experience managing multiple priorities, deadlines, and documentation activities simultaneously
- Experience communicating and collaborating with cross-functional stakeholders through verbal discussions, presentations, and written communications
- Experience using Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint
- Experience maintaining document accuracy, consistency, and compliance within a controlled environment
- Experience working independently while supporting cross-functional stakeholders in a fast-paced environment
- Must be legally authorized to work in country of employment without sponsorship for employment visa status
Benefits
Comp & perks- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
- Up to 5% domestic/international travel may be included