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 CAPAs

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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