- Overall to manage and implements Quality Management
System and Quality Improvement programs for Medical Devices manufacturing
- Oversees Quality Assurance and Compliance functions.
Work with local leadership team members in developing long and short term
business goals and strategies.
- Management of CAPA, Complaint Management System, Internal and
External Audit processes.
- Initiate and overall Management of Documentation
- Responsible to
develop and administer Quality reporting Metrics/ system for the Management.
- Align Corporate
and Site Quality Management System in ensuring consistency of Quality Management System.
- Support and maintain the local/regional Quality Management
System(s) (policies, procedures, work instructions), with
revisions and implementations of new
regional policies and
- Responsible to initiate Manufacturing Quality Systems on Equipment, Processes, Calibrations, data maintenance/
abstraction systems, CAPA, Change Control, Risk Management, etc.
- Familiar to initiate, prepare and Manage Manufacturing
Training Systems for Quality
Management and Audits.
- Responsible to provide excellent leadership and people
management skills to internal resources
in ensuring high productivity.
- Minimum Degree in Engineering, Pharmacist or related with at least
10 to 15 years of working experience in Senior/ Managerial roles.
- Proven record to effectively lead a group of Managers/ Engineers
to achieve company goals.
- Candidate must be from Medical Devices/
Pharmaceutical Manufacturing environment or related
- Candidates with the experience of manufacturing process transfers, NPI,
plant to plant, plant to suppliers and suppliers to plant.
- We look for candidates with Multinational working experience for a
global company having global and local Quality Management organizational
- Candidates must be hands-on and knowledgeable with worldwide key regulatory control for Medical Devices requirements for ISO
13485, TUV, FDA, CI, GMP from the initial stage of registration, application, approval,
administering, audit and maintenance.
- Proven track records with strong problem solving, communication and
people skills with stakeholders of different functionalities.
- Candidates with Lean, Six Sigma certifications will be an added
advantage and sought after.
- A self-starter, resourceful with an excellent project management and communication skills.
RM 20, 000