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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 regulatory standards while supporting continuous improvement initiatives. Proficient in managing documentation readiness for audits and inspections, and delivering training to cross-functional teams.
Highest-signal resume keywords
Document Control ProcessesQuality Management SystemsElectronic Document Management SystemsISO StandardsFDA Regulations
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 ManagementRecords ManagementQuality SystemsDatabase ApplicationsReport Generation
Soft Skills
CollaborationAttention to DetailProblem-Solving
Tools & Technologies
Microsoft OfficeEDMS
Industry Keywords
Regulated EnvironmentMedical DevicesPharmaceuticalsHealthcareManufacturing
About the role
Key responsibilities & impact- Establish, update, and manage documentation controls for supplier quality
- Maintain supplier quality policies, procedures, records, and controlled documents in electronic document management systems
- Conduct document audits and monitor records for compliance with internal requirements and external regulations and standards
- Maintain documentation readiness for audits and inspections
- Verify documentation completeness and accuracy before release
- Incorporate approved changes into databases
- Generate standard and custom reports
- Identify opportunities to improve documentation processes and controls
- Collaborate with quality, engineering, manufacturing, and operations teams to resolve documentation discrepancies
- Implement procedural changes and maintain training documentation
- Support continuous improvement initiatives
- Deliver Global Supplier Quality Sub-Process training to cross-functional partners
- Maintain user access profiles for record retention systems and learner role profiles within the training module
Requirements
What you’ll need- High School Diploma/GED or higher education from an accredited institution
- Five years of experience in document control, quality systems, administrative support, records management, or a related field
- Associate's degree or higher in Business, Quality, Engineering, Life Sciences, or a related discipline
- Experience working within a regulated environment such as medical devices, pharmaceuticals, healthcare, manufacturing, or quality systems
- Knowledge of document control processes and quality management systems
- Familiarity with ISO standards, FDA regulations, or other regulatory requirements
- Experience using electronic document management systems (EDMS) and database applications
- Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint
- 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
- Relocation assistance may be authorized