Quality Management System Manager (Manufacturing Plant)
Medical Devices Industry
Quality Assurance (Quality Operations)
About Our Client
A medical device company which is the headquartered in Singapore. They have R&D facilities in Japan and Singapore; a manufacturing plant in Singapore; sales and marketing offices in Europe, Japan, Singapore, and U.S
As Quality Management System Manager (Manufacturing Plant) you will be reporting to QA Director and your responsibilities will include but not limited to;
- 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.
- Execute projects as directed by supervisor
The Successful Applicant
The ideal Quality Management System Manager (Manufacturing Plant) that we are looking for should have:
- BSc in a related filed - science or engineering field.
- Related experience in a medical device/ pharmaceutical industry.
- Experience in GMP and quality assurance management.
- Strong fundamentals in quality assurance principles.
- Trained/ certified internal auditor per ISO 13485
- Familiar with ISO 14971
- People skills, project management skill and analytical skills.
What's on Offer
Continuous development and career advancement opportunities within the organisation.