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.