Description :
Position Scope/Summary Leads several key processes within the Quality Management System to assure compliance to applicable standards. Provide a significant portion of the data needed to maintain the Quality Management System of the company and also contribute to facility business performance metrics. Represent the company in a professional and exemplary manner before our suppliers, employees and community at large. Key Result Accountabilities Document Control: Develop and implement controls for the Quality Management System (QMS) and product documentation, External Standards, and customer-required specifications. Develop and maintain database systems to support the QMS. Maintain quality records, administer and record change history, and implement approved QMS changes. Control obsolete documentation, including disposition of discontinued or inactive documentation. Handle design and development history records, including product and design transfers. Update Part Master Files and BO Ms in Oracle to be consistent with hard copy . Control of Quality Records: maintain regulatory registrations, certifications, listing s and related correspondence. Ensure current and complete audit and site inspection schedules and records. Maintain current quality system records and reports, such as: audit reports and summaries; Management Review Records, and CAPA status. Maintain all current and historical Design History Files (DHF) and Device Master Records (DMR), drawings, procedures, and reports . Audits: Schedule internal systems audit and generate status reports to facilitate closure of audit findings. Assist as an Internal Auditor. Maintain the ISO QMS audit schedule and certification status. CAPA (corrective and preventive action): Document and update CAPA information related to customer complaints. Initiate, track and report on CAPA status in the current company wide system to effect change. Compliance: Administer correspondence related to registrations, certifications, and required files and listings related to quality systems, product status and procedures. Assist with customer inquiries related to quality agreements and the QMS. Notify customers of updates to quality system status (new site, new certificates, etc.). Training records: Maintain employee training records including orientation (new hire) training, and individual training requirements to applicable policies and procedures. Report on training status for company quality management systems, FDA Quality System Regulations and applicable ISO requirements when assigned. Business Metrics: Generate periodic reports on quality system metrics including specific facility metrics and corporate summaries of common facility performance metrics. Supplier Approval Process: Assist purchasing department with supplier management system. Trend supplier quality performance and ensure assessments and actions are completed as required. Maintain supplier quality records and provide quality rating feedback to suppliers. Qualifications This position requires a high school diploma or GED. Associate degree or certification as a Legal or Medical Assistant preferred. Certified training in Quality related fields and ASQ or similar certification as a Quality Auditor or Lead Assessor is preferred. Three to Five years experience with documented training in ISO-9000 / ISO13485 / FDA QSR systems will qualify in lieu of technical degree. Experience with MS-Word, Excel, Access and Power Point. Good communication skills. Must be able to balance multiple priorities. Maintain organization of quality system procedures. Complete job specific required training. Perform duties to achieve company wide quality metrics, plus business unit goals. Comply with work rules pertaining to safety, health, quality system, and Accellent Quality Management System. Oracle and Pro-Engineer/CAD experience is a plus.