Company Overview
Leading Growth Through Innovation
As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds.
You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success.
Hartalega is made up of a tight-knit, passionate and highly-skilled set of individuals.
From our top executives to our line technicians; we are all proud to be part of an elite group responsible for revolutionising the glove-making industry.
Job Description
The incumbent is responsible to manage and oversee quality assurance operations and/or inspection at both plants based at Bestari Jaya and Sepang in relation to Incoming, In-process, Final inspection, and Validation / Calibration.
Responsible for managing operational costs and budgets of the department.
Duties And Responsibilities
Business/ Operations
Managing operational costs and budgets
Managing product quality to ensure compliance with quality policies, procedures and regulations
Supervising and coordinating the manufacturing quality assurance, equipment/process calibrations/validations, compliance/documentation, microbiology and quality control activities
Developing solutions for troubleshooting analytical methods.
Leading continuous process and quality improvements.
Identifying non-conformance trends, developing and implementing technical investigations, and initiating corrective actions
Implementing preventative measures to reduce shipment failure, customer complaints and improve overall product quality
Manage and oversee QA incoming, in-process and final inspection processes supported by QA Managers at both sites.
Manage validation and calibration program.
Ensure complete, effective, and efficient.
Ensure processes developed are clearly defined with the WI/ Procedure/OPL, SOJT and Workflow.
In regards to the processes under work scope, special focus on the following:
Review and improve documentation for accuracy and completeness and fit for purpose
Ensure clarity in requirements and specifications which is clear to all stakeholders
Ensure clear workflow, PICs and escalation with identified lead time to ensure acceptable response time
Review and seek discussion on structure of QA operations to improve effectiveness and efficiency of operations and services
Generate reports on process and product capabilities using Statistical Process Control
Efficient use of resources
Propose, cascade and execute KPIs which support Corporate KPIs and goals
People/ Stakeholder Management
Leading operations teams preferably for a medium to large-scale manufacturing organization with more than 100 direct or indirect staff.
Ensure manpower in all levels of QA operations are clear on role & responsibilities and are well trained in skills and knowledge.
Working in a complex organization, navigating and influencing multiple stakeholders to achieve results
Requirements
Education:
Bachelor Degree and/or Masters in Engineering and Science.
Work Experience
Minimum 10 years of working experience in a manufacturing environment with 4 years in a managerial post.
Technical And Professional Knowledge
Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP).
Quality Management Systems related to Medical Devices i.e.
FDA QSR requirements as per 21 CFR 820, ISO 2859 Sampling Procedures for Inspection, ISO 13485: QMS, ISO 14971: Risk Management Assessment and ISO 9001.
Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
Lean manufacturing concepts and operational excellence methods and practices.
Work planning and scheduling; inclusive of operational and manpower planning.
Certification / License Requirement
N/A
Additional Company Information
Registration No.75398-K
Company SizeMore than 5000 Employees
Average Processing Time Industry21 days Manufacturing / Production#J-18808-Ljbffr