Quality Systems Specialist

About this position

The Basic Purpose and Function of this position is to independently perform quality-related functions within the Quality Department. Responsibilities include managing the review cycle of customer complaints and CAPA's, leading internal audits, assisting in SOP development, identifying training needs, facilitating the nonconformance process, supporting the Quality Management System, and performing other duties as assigned.

Job Responsibilities

• Manages the review cycle of customer complaints and CAPA’s
• Lead internal audit program
• Aid 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

Requirements

• 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
• 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