Quality Compliance Specialist

Quality Compliance SpecialistThe 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.Key Responsibilities1. Document Control & ComplianceServe 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.2. Collaboration & SupportWork 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.3. Engineering & Quality DocumentationCreate 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).4. Audit SupportSupport 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.5. Root Cause Analysis & Corrective ActionSupport 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.6. System & Data ManagementMaintain 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.Other Duties as AssignedCoach 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.Education, Experience & QualificationsHigh 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.Essential Functions and Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hand to finger, or feel, reach with hands and arms, and talk or hear.The employee must occasionally lift to 25 lbs. when necessary.Work EnvironmentThe work environment is usually in an office within a manufacturing facility with low to moderate noise level. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.Ability to work well with others, one on one, remote, via video and phone.Ability to work independently.Equal Opportunity EmployerWestfall-Technik is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex, gender, gender identity, gender expression, pregnancy, childbirth or related medical conditions, religious creed, physical disability, mental disability, age for individuals age 40 and over, medical condition (as defined by state law (for example, cancer or genetic characteristics or HIV/AIDS), marital status, military and veteran status, sexual orientation, genetic information, citizenship status or any other characteristic protected by federal, state or local law.Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.