Ensure that Illumina Quality Management System conforms to customer, internal, ISO 13485, and all medical device regulatory/legal requirements.
Manage the monitoring, measurement, review and improvement of all elements of the Quality Management System.
Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.
Manage and/or perform internal and external compliance audits/ inspections as well as lead and drive the closure of observations identified. This shall include management of corrective action program (ie, audits, inspection, recalls, field corrections) to ensure timely follow-up, completion and documentation of corrective actions.
Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
Conduct periodic management review meetings.
Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality.
Works closely with cross-functional teams in overseeing and providing regulatory guidance.
Collaborate with others in developing training materials, coordinate training activities of company employees and/or deliver training program on Medical Device regulations
Provide coaching and mentoring junior engineers
Other such duties that may be determined by Management.
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