We are seeking an experienced Quality Specialist to support product quality, compliance, and continuous improvement initiatives within a regulated manufacturing environment. This role is responsible for investigating customer complaints, conducting root cause analysis, managing nonconformances, supporting CAPA activities, and ensuring compliance with ISO 9001 and ISO 13485 standards. The Quality Specialist will work closely with cross functional teams to drive quality improvements and maintain high standards across products and processes.
The ideal candidate will have quality experience supporting mechanical and electrical assemblies, along with strong knowledge of audits, risk analysis, FMEA activities, inspection planning, and technical drawing interpretation. Experience with incoming inspection, supplier quality, SAP QM, and regulated industries such as medical devices is highly preferred.
Candidates should possess strong analytical and problem solving skills, the ability to work independently, and excellent communication skills. This is an excellent opportunity for a quality professional who enjoys hands on investigation work, continuous improvement, and ensuring products meet the highest quality and regulatory standards.