Quality Systems Specialist

Job Description Basic Purpose and Function: Independently perform quality-related functions within the Quality Department.

Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling.

Job Responsibilities: · Manages the review cycle of customer complaints and CAPA’s · Lead internal audit program · Assist in the development, revision, and control of Standard Operating Procedures (SOPs) and other controlled documents.

· Identify training needs and conduct Quality Assurance-related training to associates in tandem with the Quality Manager · Facilitate the nonconformance process and ensure timely investigation, root cause analysis, and resolution.

· Supports the maintenance and upkeep of the Quality Management System · Support performance metrics system for continual improvement · Assist with inspections, document reviews, and data entry when additional support is required to maintain production or quality timelines Other Responsibilities: · Responsible for adhering to the quality system and good manufacturing procedures · Must be able to communicate effectively with the supervisor and co-workers to provide and receive directions · Demonstrate good time management skills independent of supervision · Maintain timely and regular attendance per company policy · Performs other duties as assigned Qualifications: · Associates degree or equivalent; or 3-5 years related experience and or training; or equivalent combination of education and experience in medical device manufacturing · Proficient in applicable regulations/standards (ISO 13485, FDA, etc.) · Ability to read, analyze, and interpret general business periodicals, professional journals, or governmental regulations.

· Ability to write reports, business correspondence, and procedure manuals · Ability to effectively present information and respond to questions from employees, supervisors, managers, executive staff, customers, and suppliers · Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions · Proficiency in Microsoft Word, Excel, and Outlook or similar e-mail programs · Responsible for adhering to the quality system and good manufacturing procedures · Must be able to communicate effectively with the manager and co-workers to provide and receive direction · Demonstrate good time management skills independent of supervision · Maintain timely and regular attendance per company policy Physical Requirements: · Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions · The associate must occasionally lift and/or move up to 40 pounds · Specific vision abilities required by this job include close vision and the ability to adjust focus PI4580cadb1124-25405-40413670