Quality Systems Specialist

Overview

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.

• 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 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

• 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

• Associate’s 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

• 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