Quality Assurance Specialist, Logistics, APAC

Getinge South East Asia Pte Ltd; Singapore; On-site; SGD 48,000 - 65,000; Full time

Job summary

A leading healthcare solutions provider in Singapore is seeking a Quality Manager for Logistics. This role requires supporting the establishment and maintenance of quality systems, compliance with ISO standards, and management of supplier quality agreements within the APAC region. Ideal candidates have a background in life sciences or engineering, experience in quality assurance within the medical device industry, and strong communication skills. Will involve travel and collaboration across various teams.

Qualifications

• At least 2 years working experience within Quality Assurance for Logistics or manufacturing.
• Experience in internal and external audits (ISO 9001 or ISO 13485).
• Hands-on mentality with the ability to teach elements of quality logistics.

Responsibilities

• Support establishment of quality related procedures.
• Perform regulatory reporting of FSCAs to Health Sciences Authority.
• Support internal/external audits for logistics procedures.

Skills

Quality Assurance

Communication

Team collaboration

ISO9001 knowledge

Logistics knowledge

Education

Bachelor degree in Life Sciences, Engineering, Logistics, or Quality Management

Job description

Job Purpose

• Provide support for establishing and maintaining the quality management system for Global Logistics to be compliant with international standards/regulations and GetQMS directives.
• Provide support for the quality assurance function, Quality manager Logistics (LQO), in ADC. Backup for LQO ADC.
• Support main stakeholders in the optimization and improvement of product flows across the entire distribution chain.

Functions

• Actively support the APAC Logistics organization in the implementation, maintenance, and continuous improvement of Getinge Quality System including change management.
• Support Logistics supplier management from APAC QA Logistics standpoint by supporting performance monitoring, audit when necessary and documentation as per Getinge requirements.
• Provide partnership and support to Business Unit (BU) / Global Sales (GS) for APAC Logistics Quality topics.
• Lead / support, as QA representative, in projects, changes and improvements affecting APAC Logistics operations.
• Perform and support supplier / internal audits.
• Coordinate Quality Hold for ADC.
• Perform FSCAs related activities.
• Perform regulatory reporting of FSCAs to HSA (Health Sciences Authority).

Key Duties and Responsibilities

As a Quality Management System and Compliance:

• Support the establishment of quality related procedures.
• Support in establishing, reviewing, improving logistical procedures in Getinge Quality System.
• Support in developing training material and performing training for logistics procedures.
• Support compliance of Global Distribution Center APAC (ADC) to Standards, Regulations, and Getinge requirements.
• Support in internal/ external audits for logistics procedures.
• Support management of CAPAs related to quality deviation in APAC Logistics.

As a Supplier Management:

• Support establishing Supplier Quality Agreement with Global Distribution Center in APAC (ADC) and related suppliers.
• Be responsible for or support communication, preparation, and follow up of supplier audit at Distribution Center in APAC (ADC) and related suppliers.
• Be responsible for or support SCAR management at Distribution Center in APAC (ADC) and related suppliers.
• Take active part in Gemba walks in warehouse to identify deviations and improvements. Share best practice with all DCs.Participate in operational/ business review meetings with Global Distribution Center in APAC.
• Lead, support or participate supplier audit as per Supplier Audit Program.

As a Support to Key Stakeholders:

• Support Logistics Operations in the implementation, maintenance, and continuous improvements of Getinge Quality System.
• Support Logistics Operations by ensuring monitoring/ managing blocked stock.
• Support Logistics Operations in analysing trends and in identifying improvements. Drive or support change to improve and standardize process.
• Support Regional QRC in quality approval and in drafting of quality agreements of warehouses.
• Support Regional QRC in communication, preparation, and follow-up of supplier audits at warehouse.
• Ensure best practice sharing with Regional QRC.
• Ensure support to Getinge Business Units (BU) in Quality related activities to be performed at Distribution Center in APAC.
• Ensure support in implementation of specific / value added activities requested by Getinge Business Units (BU) to be performed at Distribution Center in APAC.

As Project Key Person

• Support or lead APAC Logistics Quality related projects.
• Act as Quality specialist within project affecting Logistics APAC.

For Quality Systems

• Build quality into all aspects of their work by maintaining compliance to all quality requirements.

Others

• Travel required in line with support on APAC set-up (Distribution Center, Warehouses, Transport).
• A strong team player with communication skills.
• Perform any ad-hoc duties assigned by the Line Manager and/or the Company.

Knowledge/ Skills/ Experience

• Academic background (Bachelor degree) in Life Sciences, Engineering, Logistics, or Quality Management.
• At least 2 years working experience within Quality Assurance for Logistics or manufacturing, preferably within Medical Device industry.
• Knowledge of ISO9001, ISO13485 is preferred.
• A strong team player with strong communication skills.
• Experience in internal and external audits (ISO 9001 or ISO 13485).
• Travel required in line with support of APAC activities (Distribution Center, Warehouses, Transport).
• Successful interaction in cross functional environment and the ability to build strong interpersonal relationships.
• Excellent communication skills with an equally good ability to listen.
• Hands on mentality with the ability to teach elements of quality logistics.
• The role requires international travel. Travel anticipated to average 5% annually but may vary depending on project needs.