Primary Responsibilities:
Interface with all departments in the organization in matters related to the quality system compliance.
Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).
Support the Internal Audit program and provide backroom support for External Audits (Regulatory, Notified Body, and Customer).
Assist in the management of a Calibration and Preventative Maintenance program.
Disposition non-conforming material (NCMR).
Support product complaint investigations leading to root cause determination.
Support updates to the Risk Management File (FMEA, Hazard Analysis, Post Market Surveillance Reports, etc.).
Review and as needed update QMS procedures (SOPs, Work Instructions, Forms) to reflect latest industry standards, guidance documents and best practices.
Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification).
As appropriate, assist in supplier qualification activities (initial assessments and categorization).
Other duties as assigned by manager.