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Quality Compliance Specialist
Westfall Technik, LLC. Manage and maintain the document control system .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in document control management, ensuring compliance with quality management systems and regulatory requirements. Proficient in maintaining document libraries, conducting audits, and supporting quality compliance initiatives.
Highest-signal resume keywords
Document Control ManagementQuality Compliance ExperienceERP Systems KnowledgeControlled Document ManagementAudit Preparation Support
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 Control System ManagementQuality Management Systems ComplianceSOP Development and ImplementationRoot Cause Analysis (8D, 5 Whys, Fishbone)Device History Records (DHR) ManagementEngineering Drawing ReviewCorrective and Preventive Actions (CAPAs)Document Archiving and Version ControlTraining on Document Control ProceduresDocumentation Flow Management
Soft Skills
CollaborationIndependent WorkCommunicationCoachingAttention to Detail
Tools & Technologies
IQMS Document Control SystemDigital Document LibrariesFiling SystemsDocument Management SoftwareQuality Compliance Tools
Industry Keywords
Regulated Industry ExperienceOperations QualityCompliance Audit SupportQuality ProceduresDocument Retrieval and Access
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Manage and maintain the document control system
- Ensure documents comply with quality management systems and customer and regulatory requirements
- Serve as primary point of contact for controlled document storage, access, retrieval, and reference
- Maintain the IQMS document control system, including templates, logs, and revision control
- Archive obsolete documents and ensure proper versioning of quality procedures, work instructions, forms, and logs
- Review documents for alignment with current standards and practices
- Distribute, update, and remove controlled printed copies as revisions are released
- Prepare and organize documentation for new production or sample run start-ups
- Notify affected personnel of document changes using standardized templates and workflows
- Provide training and support on document control procedures and IQMS systems
- Manage documentation flow, routing, and approvals
- Create fixture numbers for quality and production systems
- Assist with SOP development and implementation for document creation, revision, and archival
- Conduct final review and archive of Device History Records (DHR)
- Support internal and external audit preparation and activities
- Maintain the internal audit program, auditor assignments, schedules, reports, and action closeout
- Support structured root cause analysis using 8D, 5 Whys, and Fishbone analysis
- Track, verify, and sustain corrective and preventive actions (CAPAs)
- Maintain digital and physical document libraries, filing systems, indexes, traceability, accessibility, and security
- Coach internal teams on document management and quality compliance practices
- Provide requested documentation and audit trails
- Handle scanning, filing, template updates, and document review scheduling
- Perform other assigned duties and projects
Requirements
What you’ll need- High School Diploma or Equivalency required
- Associate Degree in Science or equivalent education preferred
- Minimum of 5 years of operations quality or compliance experience in a regulated industry
- Experience in supporting quality compliance audit
- Working knowledge of ERP systems
- Experience managing controlled documents
- Working knowledge of reviewing engineering drawings
- Ability to work well with others, one on one, remote, via video and phone
- Ability to work independently
- Ability to stand, walk, sit, use hands and fingers, reach with hands and arms, and talk or hear
- Ability to occasionally lift up to 25 lbs.
- Must meet applicable work authorization requirements (not explicitly stated; no specific country requirement)
Benefits
Comp & perks- Equal Opportunity Employer
- Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions