Job Description

East , Tampines
Negotiable
17 Nov 2023

Executive
2-4 years

Person-In-Charge: Joni (R1106641)
Email:
Contact: 6566 5498

Reponsibilities

ISO 13485 /ISO 9001: Quality Management System

• Maintain the QMS to meet the requirements of the latest ISO 13485/ISO9001
• Perform Internal Audits to SAP and external audit to Affiliates and BP (when required) according to ISO 13485/ISO9001 requirements
• Perform Supplier Audits as and when necessary
• Conduct Management Review as according to ISO 13485/ISO9001 requirements.
• Responsible for the internal CAPA process for both factory and office.
• Serve as primary PIC for quality complaint management system.

ISO 14001 Environmental Management System

• Maintain the EMS of SAP to meet the requirements of ISO 14001
• Perform Internal Audits according to ISO 14001 requirements
• Conduct Management Review as according to ISO 14001 requirements.
• Monitoring and improvement of Environmental Management Programs.
• Cultivate an environmental mindset in the organization
• Ensure waste disposal are done in according to the regulation

Workplace Safety and Health

• Maintain and update the risk registers for factory and office.
• Establish and implement work safety procedures for both factory and office.
• Conduct Safety Audit for SAP (include offices, training center and warehouse)
• To ensure compliance to all necessary regulations such as poison license, hazardous substance license.
• Establish and implement work safety procedures for both factory and office
• Handle and monitor QCHF
• Keep monitoring customer complain from customers/business partners in Asia Pacific Global Communication Database regularly.
• When the complaint is going to be the quality issues, collect enough information and actual stuffs for the investigation by manufacturers and escalate it to the Track Wise (complaint tracking system)
• Keep contact with manufacturers and complaint sender by closing the issues.
• Explain the conclusion effectively and timely until closed by the customer/business partner, not spare any effort to be customer satisfaction.

Change Control

• Act as a coordinator for the Change Control assessment request from Company
• Assist the Change Control Manager in disseminating the Change Control (CC) information to the appropriate stake holders, serve as coordinator to collect the impact assessment result from the stakeholders and assist the Change Control Manager to consolidate and send back the Change Control to the manufacturer. Support the Change Control manager to handle the subsequent Change Control processes accordingly when needed.
• Monitor and update the status of the Change Control
• Computer System Validation processes
• Act as Solution Manager administrator

Requirements

• Min Diploma / Bachelor Science in Bioengineering / Engineering (electrical / electronics) / Quality Management
• Min 2 years experience in Quality Assurance role in Healthcare industry - manufacturing / trading or distributors firms
• Certified Lead Auditor for ISO13485/ISO 9001
• Knowledge and experience in ISO 14001 internal audit and Workplace Safety and Health requirements
• Knowledge of ISO 13485 / ISO 9001 QMS, ISO 14001 EMS, Workplace Safety and Health Act.

Additional Information

Interested candidates, please forward detailed resume in MS Word Format to joni@hkmsvs.com or contact 6566 5498 for more details.

Please provide following information in the resume

1) Reasons for leaving current and/or last employment
2) Last drawn and/or current salary
3) Expected salary
4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

HKM HR Management