DESKRIPSI PEKERJAAN
Leads project in collaboration with Department Heads of the Factory and Regions to align on and implementation of desired QMS changes.
Secondary focus - manage Global QMS for HSO Headquarter.
Responsible for ongoing maintenance and certification of the Factory QMS.
Owns and drives the internal audit, external audit and supplier audit program.
Collects, organize and analyses quality performance of the QMS for management review meeting and initiate improvement projects.
Oversee Manufacturing Plant’s QMS processes such as, but not limited to management review, internal audit, external audit, supplier management, document/ records control, change control, CAPA, software validation, training, Device Master Record, risk management and analysis of quality performance data.
Support the processes of software validation.
Interface and communicate promptly with Factory and Regions for issues relating to Change Control and CAPA processes to ensure timely closure and implementation effectiveness.
Manage and oversees Global QMS for HSO Headquarter.
Execute projects as directed by supervisor
REQUIREMENT
Bachelor degree in a science or engineering field.
Strong fundamentals in quality assurance principles.
Trained/ certified internal auditor per ISO 13485
Familiar with ISO 14971
Excellent verbal, written communication and detail-oriented.
Be able to lead constructive debate about product quality with co-workers and suppliers.
People skills, project management skill and analytical skills.
Able to work within international environment.
Able to lead and coach cross-functional teams.
Proficient at Microsoft Office.
Statistical tools/ software, added advantage.
DETAIL LOWONGAN
- Umur -
- Min GPA -
- Min. Qualification S1/D4
- Min Experience Manager / Assistan Manager
