Senior Manager Quality, Logistics, APAC

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:

The Senior Manager, Quality Logistics is responsible for leading Quality and Compliance to international and local regulations for all products managed at the Global Logistics APAC Distribution Center located in Singapore. This includes products manufactured at 22 Getinge global facilities, spare parts, accessories and disposables, that are distributed globally from the site.

The Senior Manager is also responsible for Quality and Compliance oversite of additional value-added activities including customer returns, product returns from customer complaints, country-specific labeling and field actions.

The position will be part of the site leadership team and will be responsible for administering, maintaining and improving the Logistics Quality Management System that meets all ISO13485 and local requirements. This position will lead team of Quality Specialists at the site and partner with Getinge Operations and Planning teams to assure Getinge customer needs and expectations are consistently met.

Functions:

• Actively support the APAC Logistics organization in the implementation, maintenance, and continuous improvement of Getinge Quality System including change management.
• Secure Logistics supplier management from APAC QA Logistics standpoint by ensuring approval, performance monitoring, audit when necessary and documentation as per Getinge requirements.
• Manage allocated resources as per position description and operational needs.
• 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 audits.
• Coordinate Quality Hold for ADC
• Perform FSCAs related activities.
• Perform regulatory reporting of FSCAs to HSA (Health Sciences Authority).

Key duties and responsibilities:

• Provide strategic and tactical leadership of Quality at the Global Logistics Operations at the APAC Distribution Center in Singapore.
• Maintain and improve an effective and compliant Quality Management System including the development of electronic processes and record management.
• Develop a competent and accountable Quality organization that is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance. Assure the business functions operate in compliance with applicable domestic & international requirements, laws and guidance. Engaging relevant authorities as required for approvals/ licensing. 
• Provide strategic and tactical leadership of Quality at the Global Logistics Operations at the APAC Distribution Center in Singapore. 
• Maintain and improve an effective and compliant Quality Management System including the development of electronic processes and record management.
• Develop a competent and accountable Quality organization that is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance. Assure the business functions operate in compliance with applicable domestic & international requirements, laws and guidance. Engaging relevant authorities as required for approvals/ licensing.
• Drive and implement the Logistics Quality Management System structure.
• Has established responsibility and authority for the following:
  • • Ensuring that the quality management system is effectively defined, documented, implemented, and maintained.
    • Reporting to top management on the performance of the quality management system.
    • Authority to act on behalf of top management during audits (internal and external).
    • Authority to place products or processes on hold.
    • Managing quality audit functions
• Perform the role of APAC Distribution Management Representative. 
• Oversee third party quality systems inspections and audits (ISO 13485, corporate, etc).
• Support on supplier qualification and quality management processes.
• Lead preparation of third-party audit responses.
• Work with cross functional teams to establish quality metrics that align to the corporate goals and develop and implement Quality Plans to assure the goals are met.
• Support continuous improvement initiatives with Logistics Service providers.
• Develop a Quality program which drives personal accountability for accuracy, consistency, and completeness for Logistics.
• Partner with Global Logistics and other Quality teams to effectively create and support process and quality enhancement initiatives to create and maintain an environmental of excellence and continuous improvement across all Getinge Logistics sites, globally.

Minimum Requirements

• Bachelor’s degree in technical field or equivalent.
• A minimum of 10 years’ experience in Quality Assurance within an ISO13485 (or equivalent) regulated company, of which at least 5 years of managerial experience.
• Progressive leadership experience including hands on advanced quality system strategy.
• Hands-on experience of handling DC warehouse/ manufacturing operations quality.
• Excellent knowledge of regulatory compliance for medical devices.
• Demonstrated knowledge of Quality System Regulations and Quality System Inspections.
• Strong influencing skills and the ability to build strong interpersonal relationships.
• Excellent communications skills including public speaking and strong written skills.
• Demonstrated leadership within a cross-functional environment.
• Advanced skills in MS Office applications (Word/ Excel) are required.
• Fluent in English.

Required Knowledge, Skills and Abilities

Leadership Competencies

• Communication – Demonstrated ability to communicate effectively oral and written form at executive level.
• Interpersonal – Ability to develop and sustain positive and collaborative relationships with internal as well as external customers.
• Managerial – Coach, develop and motivate associates to optimize team effectiveness and enhance team collaboration.

Supervision/ Management of Others

• Responsible for the development and management of employees in the Quality Organization.
• Oversee utilization of external contractors from skill sets and cost perspective.

Environmental/ Safety/ Physical Work Conditions

• Duties are performed in an office environment or as assigned by the Company.
• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/ devices to complete assignments.
• May work extended hours during peak business cycles.
• Travel requirement – 10%

Special Features/Conditions:

The role requires international travel. Travel anticipated to average 10% annually but may vary depending on project needs.

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.