(Sr.) Quality System Manager/Specialist_TC21946

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Essential Duties and Responsibilities

* Create, review, update, improve and maintain the department processes and documents for better teamwork and high-quality products.

* Manage and perform the internal audit, ISO related activities and projects across multiple teams and departments.

* Coordinate external audits by the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings.

* Coordinate internal audit program including planning, implementation, report generation, corrective action issuance to closure.

* Create and coordinate appropriate and effective Corrective and Preventive Actions (CAPA).

* Conduct local and global training on key elements of the QMS, EMS and Information security management (ISM), including CAPA, Complaint and Internal Audit.

* Execute projects and complete other duties as assigned.

Qualifications

* Bachelor’s degree in EE-related, CS, CE or a related field.

* Minimum of 5 years working experience in software, firmware or hardware engineering or a related field.

* Knowledge of Information security management (ISM) and ISO International Standards, such as ISO 9001, 13485, 14001, 27001, AS9100, etc.

* Strong communication skills across multiple teams and departments

* Excellent presentations skills (articulate and persuasive); demonstrated good English written and verbal skills

* Excellent analytical, problem solving and decision making skills

* Willingness to “do what it takes,” including direct auditing activities at times

* Must be a strong individual contributor and able to work independently and within a team