Quality Compliance Specialist

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The Quality Compliance Specialist is responsible for the management and maintenance of the document control system, ensuring documents are compliant with established quality management systems as well as meeting customer and regulatory requirements, assisting both internal and external audits, and assisting in and driving root cause analyses. The successful candidate will collaborate cross-functionally with engineering, quality, and operations teams to maintain high standards of document integrity and availability.

• Serve as the primary point of contact for controlled document storage, access, retrieval, and reference.
• Maintain IQMS document control system including document templates, logs, and revision control.
• Archive obsolete documents and ensure proper versioning for controlled copies of Quality Procedures, Work Instructions, Forms, and Logs.
• Review all documents to ensure alignment with current standards and practices.
• Ensure controlled printed copies are distributed to the appropriate teams and removed/updated as revisions are released.
• Work closely with project managers, engineers, and the quality team to 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 to internal teams and external stakeholders.
• Manage documentation flow throughout the organization, ensuring timely routing and approvals.

• Create fixture numbers for use in quality and production systems.
• Assist in the development and implementation of SOPs for document creation, revision, and archival.
• Responsible for the final review and archive of DHR (Device History Record).

• Support both internal and external audits, assist in audit preparation and auditing activities.
• Support addressing audit observations.
• Ensure internal audit program is up to date with approved scheduling, appropriately trained auditors assigned, and audit reports are completed.
• Ensure close out of open actions generated from the audits in a timely manner.

• Support structured problem-solving using tools such as 8D, 5 Whys, and Fishbone analysis.
• Track, verify, and sustain corrective and preventive actions (CAPAs).
• Ensure CAPA content meets requirements, have a robust root cause analysis, appropriate actions implemented and effective verification checks.

• Maintain digital and physical document libraries ensuring traceability, accessibility, and security.
• Develop and support initiatives to improve legacy and current document control systems.
• Maintain organized filing systems and document indexes to support internal audits and compliance reviews.

• Coach and guide internal teams on proper document management practices and the use of document control systems.
• Coach and guide internal teams on ensuring meeting all quality compliance, customer and regulatory requirements.
• Support internal and external audits by providing requested documentation and audit trails.
• Handle administrative duties such as scanning, filing, updating templates, and scheduling document review cycles.
• Perform other duties and projects as assigned by supervisors.
• Take on additional responsibilities as needed to support the team and meet operational priorities.

• High School Diploma or Equivalency…