Quality Systems Specialist

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

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