Quality Systems Coordinator II
Core
Support the sustaining of the Quality System for the Plant, ensuring compliance with Quality Management Systems and Regulatory Compliance.
Role type
Quality Systems Coordinator
Builds
Quality Management System documentation and regulatory compliance processes
Domain
Manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Quality Management System (QMS) maintenance, Corrective and Preventive Actions (CAPA) management, Customer Complaint investigation support, Internal Audit participation, Good Manufacturing Practices (GMP) compliance, ISO 13485 knowledge, CFR Part 820 knowledge, Problem Solving methods, Metric tracking
Preferred skills
Industrial Engineering background, English proficiency
Technologies
None explicitly stated
Responsibilities
Guarantee full compliance of ACA, CAPA, and Customer Complaint investigations; Follow up on open Quality Figures; Serve as a coach to the Investigator; Coordinate and measure QMS maintenance activities; Maintain metrics for the Plant regarding quality figures; Assist in External Audit preparation; Ensure corrective actions are completed per ISO requirements; Participate in the Internal Auditors Team; Provide support to Release area activities
Seniority
Mid-level, hands-on IC