Quality Specialist

Responsibilities

• Scans records and files in appropriate SharePoint locations.
• Nonconformance reports – reviews information, investigates, adds objective evidence, and routes NCR for closure.
• Verifies the nonconforming goods were placed in the NCR room each day and the information on the NCR matches the quantity and description of products.
• Reaches out via email or in person to team members to obtain any missing information regarding investigating NCRs.
• Reviews purchase orders and maintains PO Log and receipt of purchase product inspection form.
• Updates training matrix log
• Assists in documenting and scanning records.
• Understands ISO requirements, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance.
• Develops and performs to Quality, Operational and Performance Metrics.
• Provides input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.
• Interacts with quality managers to discuss project planning cross-functional QMS procedures.
• Engage, interact and respond in a prompt, accurate, courteous and poised manner to encourage positive business relationships.
• Consistently demonstrates a positive, constructive, and cooperative attitude in the business environment.
• Effectively complete “other” functions and tasks as assigned by quality management.

Qualifications

• Minimum 1 year experience in Quality (CFR820 and/or ISO 13485).
• Previous experience in Med Device strongly preferred.
• General understanding of Quality Management Systems.
• Experience working in a matrix environment in which collaboration in all directions is necessary.
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint).
• Experience working in a fast-paced rapidly growing environment.
• Excellent communication both verbal & written.
• Able to lift up to 50 pounds.