The Director of Quality ensures that the organization’s products and services are in compliance with the company’s quality requirements, in addition to complying with customer and regulatory requirements for quality, safety, and reliability.

Reports directly to the Sr. Director of Quality for Genetic Science Division and works with the Marsiling, Tuas and SUT manufacturing site leaders on all topics, processes and strategy that affect the quality of goods and services provided to our customers.

• Responsible for the development, implementation, and strict adherence to a quality program.
• Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of products, including suppliers and OEM. The Director of Quality has the ultimate authority and decision, placing product on hold, over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards.
• Reviews and resolves quality control problems/concerns with Quality Managers, and others including vendors, customers, quality control personnel, and any personnel related to production.
• Coordinates and assists with regulatory and notified body, customer and, vendor inspections.
• Oversees the process for periodical review of completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards.
• Directs internal audit program, and develops corrective action plans and ensures timely resolution of findings.
• Receives and reviews customer satisfaction surveys, customer contacts and complaints. Reviews complaint trends and product/component failure analysis; reviews corrective actions with appropriate personnel.
• Responsible for directing/preparing reports and other documentation required by regulatory agencies
• Directs the operation’s ISO 9001, ISO 13485, ISO14001, OHSAS 18001 and WHO Good Distribution Practice certification and FDA 21 CFR part 820 compliance by providing leadership and coordinating different functional activities.
• Provide direction, for other functions that have an effect on product quality.
• Act as a liaison with corporate and external parties relating to quality, product regulatory compliance issues.
• Prepare and manage a program to communicate to leadership team within the division, and other ThermoFisher divisions and corporation.
• Maintain a highly skilled staff to allow for timely investigations, process improvements, and as the quality representative drive all practices to allow for the success and high quality product to our customers.
• Direct a staff of up to 10 direct reports and their staff.

Minimum Requirements

• A Degree in Engineering or Sciences
• Min 5-8 years' experience working in a Quality Assurance function in a management role.
• Preferably medical device / IVD industry experience but will consider other industry of quality management and skills sets are met.

Competencies Preferred

• Able to manage in a global matrix organisation environment
• Ability to handle uncertainty and mitigate risk
• Able to think strategically, creatively and rationally.
• Strong communication (verbal and written) and good interpersonal skills with all levels
• Strong planning, negotiation and organising skills