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
PI285674497
