Quality Assurance Specialist, Logistics, APAC

Getinge South East Asia Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Getinge South East Asia Pte Ltd seeks a Quality Management System and Compliance specialist to support APAC logistics quality, establish procedures, and ensure compliance with ISO9001/13485 and GDP. You will collaborate with BU and GS, perform supplier audits, and coordinate quality holds for ADC, travelling as required.

The role requires 3–5 years in QA for logistics or manufacturing, strong communication, and a hands-on approach to drive continuous improvements across the distribution network

Qualifications

• 3–5 years of experience in Quality Assurance for Logistics or manufacturing.
• Knowledge of ISO 9001 and ISO 13485 and/or GDP is required.
• Strong communication and teamwork skills.

Responsibilities

• Support the establishment of quality procedures.
• Support in establishing and reviewing logistical procedures in Getinge Quality System.
• Develop training material and perform training for logistics procedures.
• Support compliance of Global Distribution Center APAC (ADC) to standards and Getinge requirements.
• Support internal and external audits for logistics procedures.
• Support management of CAPAs related to quality deviations in APAC Logistics.

Skills

Quality Assurance

Auditing

ISO 9001 knowledge

ISO 13485 knowledge

Quality systems

Communication skills

Teamwork

Education

Bachelor Degree in Life Science, Engineering, Logistics, or Quality Management

Job description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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 Logisitcs (LQO), in ADC. Backup for LQO ADC.
• Support main stakeholders in the optimization and improvement of product flows across the entire distribution chain.

Function

• Activly support and collaborate with the APAC Logistics organization by implementing, maintaining, and continuously improving the Getinge Quality System, including supporting operational processes from a quality aspect to ensure compliance.
• Support Logistics supplier management by supporting performance monitoring, audit when necessary and documentation as per Getinge requirements.
• Partner with Business Units (BU) and Global Sales (GS) to address APAC Logistics Quality topics, providing solutions that enhance compliant warehouse processes.
• Support projects, change 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 Standrads, 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, including supporting quality related operational activities at the warehouse.
• Support Logistics Operations by ensuring monitoring/ managing blocked stock.
• Support Logistics Operations in analyzing 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 Unit (BU) to be performed at Distribution Center in APAC.

As Project Key Person:

• Support APAC Logisitcs Quality related proejcts.
• Act as Quality Specialist ithin project affecting Logistics APAC.

Others:

• Travel require 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.

Quality System Duties and Responsibilities:

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

Knowledge/ Skills/ Experience

• Academic background (Bachelor Degree) in Life Science, Engineering, Logistics, or Quality Management.
• At least 3-5 years working experience within Quality Assurance for Logistics or manufacturing, preferably within Medical Device industry.
• Knowledge of ISO9001, ISO13485 and/or GDP is required.
• 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).
• The role requires international travel. Travel anticipated to average 5% annualy but may vary depending on project needs.

Personal Qualities:

• 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.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.