Quality Compliance Specialist

Quality Compliance Specialist 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 Key Responsibilities 1 Document Control & Compliance Serve as the primary point of contact for controlled document storage access retrieval and referenceMaintain IQMS document control system including document templates logs and revision controlArchive obsolete documents and ensure proper versioning for controlled copies of Quality Procedures Work Instructions Forms and LogsReview all documents to ensure alignment with current standards and practicesEnsure controlled printed copies are distributed to the appropriate teams and removedupdated as revisions are released2 Collaboration & Support Work closely with project managers engineers and the quality team to prepare and organize documentation for new production or sample run start upsNotify affected personnel of document changes using standardized templates and workflowsProvide training and support on document control procedures and IQMS systems to internal teams and external stakeholdersManage documentation flow throughout the organization ensuring timely routing and approvals3 Engineering & Quality Documentation Create fixture numbers for use in quality and production systemsAssist in the development and implementation of SOPs for document creation revision and archivalResponsible for the final review and archive of DHR Device History Record4 Audit Support Support both internal and external audits assist in audit preparation and auditing activitiesSupport addressing audit observationsEnsure internal audit program is up to date with approved scheduling appropriately trained auditors assigned and audit reports are completedEnsure close out of open actions generated from the audits in a timely manner5 Root Cause Analysis & Corrective Action Support structured problem solving using tools such as 8D 5 Whys and Fishbone analysisTrack verify and sustain corrective and preventive actions CAPAsEnsure CAPA content meets requirements have a robust root cause analysis appropriate actions implemented and effective verification checks6 System & Data Management Maintain digital and physical document libraries ensuring traceability accessibility and securityDevelop and support initiatives to improve legacy and current document control systemsMaintain organized filing systems and document indexes to support internal audits and compliance reviewsOther Duties as Assigned Coach and guide internal teams on proper document management practices and the use of document control systemsCoach and guide internal teams on ensuring meeting all quality compliance customer and regulatory requirementsSupport internal and external audits by providing requested documentation and audit trailsHandle administrative duties such as scanning filing updating templates and scheduling document review cyclesPerform other duties and projects as assigned by supervisorsTake on additional responsibilities as needed to support the team and meet operational prioritiesEducation Experience & Qualifications High School Diploma or Equivalency requiredAssociate Degree in Science or equivalent education preferredMinimum of 5 years of operations quality or compliance experience in a regulated industryExperience in supporting quality compliance auditWorking knowledge of ERP systemsExperience managing controlled documentsWorking knowledge of reviewing engineering drawingsEssential Functions and Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this jobReasonable accommodation may be made to enable individuals with disabilities to perform the essential functionsWhile 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 hearThe employee must occasionally lift to 25 lbs when necessaryWork Environment The 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 phoneAbility to work independentlyEqual Opportunity Employer Westfall 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 HIVAIDS 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