Quality Systems Specialist

Position Summary.

The Quality Systems Specialist supports the implementation and maintenance of the Quality Management System (QMS) in compliance with FDA regulations and ISO 13485 standards. This role is primarily responsible for managing complaint handling and document control processes to ensure product safety, regulatory compliance, and continuous improvement.               

Essential Duties and Responsibilities. 

·         Receive, document, and perform risk assessments for product complaints in accordance with FDA 21 CFR Part 820, 803 and ISO 13485 requirements.

·         Coordinate complaint investigations with cross-functional teams including customer support, engineering, manufacturing, and quality.

·         Execute document control responsibilities and facilitate the change control process from initiation through implementation in the Nuclein electronic Quality Management System (eQMS), including review of change requests to ensure compliance to procedures.

·         Assign training to employees on new/revised documents in the eQMS according to procedures

·         Provide support and training for end users on the document control process and system.

·         Assist in the preparation of metrics and reports related to document control, complaint handling, training and other QMS activities.

·         Maintain physical and electronic quality records.

·         Maintain equipment files and associated records.

·         Support regulatory inspections, internal, and third-party audits.

·         Perform other duties and responsibilities as assigned.

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in any field required.

·         Minimum 2 years of experience working in Medical Devices/Pharma cGMP, ISO 13485 or 21 CFR 820/803 environments required.

·         Experience processing medical device complaints strongly preferred.

·         Strong computer and system skills (e.g. Word, PowerPoint, Excel).

·         Excellent interpersonal skills both written and oral communication

·         Detailed oriented with strong organizational skills

Physical Requirements.  

·         Repetitive Motion: Mostly computer use 

·         Weight Lifting: < 25 lbs 

·         Position: Mostly sitting 

·         Speaking and communicating 

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas