Senior Quality & Lab & Safety Manager

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading research organization in Singapore seeks a Senior Quality, Lab and Safety Manager. This role involves developing quality management systems, overseeing laboratory operations, and ensuring compliance with safety regulations. Ideal candidates will have 7-10 years of experience in quality management and lab operations, particularly in medical devices, and demonstrate strong leadership abilities. Candidates should also possess excellent problem-solving and communication skills. Competitive remuneration and a supportive work environment are offered.

Qualifications

• Minimum 7 to 10 years of experience in quality management and laboratory operations.
• Strong knowledge of ISO13485, GLP, GMP, and EHS regulations in Singapore.
• Proven experience establishing and maintaining QMS in regulated environments.

Responsibilities

• Develop and maintain quality management systems to ensure compliance.
• Oversee laboratory operations and readiness for medical device projects.
• Lead laboratory safety programs and manage risk assessments.

Skills

Quality management

Laboratory operations

People management

Analytical skills

Problem-solving

Project management

Regulatory compliance

Education

Degree in Engineering or Life Sciences

Postgraduate qualification preferred

Job description

MedTech Catapult is a national initiative to accelerate the productisation and commercialisation of high-value MedTech products and to strengthen Singapore's MedTech innovation ecosystem. The in-house product engineering and development team provides end-to-end design & development and verification & validation capabilities. The Senior Quality, Lab and Safety Manager will play a critical role in establishing robust quality systems, ensuring laboratory compliance and safety, and enabling the smooth operation of technical facilities to support translational success. The Senior Quality, Lab and Safety Manager will report to the Lead, Product Development.

Job Responsibilities

• Develop, implement, and maintain quality management systems (QMS) to ensure compliance with ISO13485, Good Laboratory Practice (GLP), and other applicable safety and regulatory standards.
• Oversee day-to-day operations of laboratory facilities, maintaining laboratory readiness for design verification, validation, and testing activities across multiple FDA Class II and Class III medical device projects
• Function as MedTech Catapult's appointed Fire Safety Officer and Workplace Safety Health Officer liaising with A*STAR Corporate Services, regulators, and public agencies on safety and compliance matters including hazardous materials handling, relevant license application and renewal.
• Lead and manage laboratory safety programmes, including risk assessments, audits, emergency preparedness, incident reporting, management of contractors, safety induction, access control, waste management, laboratory environment monitoring, laboratory asset management and workplace safety training.
• Establish and maintain quality documentation processes, including standard operating procedures (SOPs), work instructions, validation reports, equipment list, equipment usage, facility safety and records management.
• Support project teams by ensuring quality and safety considerations are embedded throughout product design, prototyping, and testing.
• Support onboarding of new internal or external project teams requiring lab space for design and verification activities
• Mentor and supervise junior staff and officers on laboratory safety, quality processes, and operational best practices.
• Manage laboratory equipment calibration, preventive maintenance, and procurement to ensure operational readiness.
• Drive continuous improvement initiatives in quality, laboratory operations, and workplace safety.
• Represent MedTech Catapult in audits, inspections, and certification exercises with external regulatory authorities and partners.

Requirements

• Degree in Engineering, Life Sciences, or a related discipline; postgraduate qualification preferred.
• Minimum 7 to 10 years of experience in quality management, laboratory operations, and workplace safety, preferably in medical devices, pharmaceuticals, or life sciences.
• Strong knowledge of ISO13485, GLP, GMP, biosafety, and workplace safety regulations in Singapore.
• Familiarity with laboratory audits, equipment qualification (IQ/OQ/PQ), and facility validation.
• Proven experience establishing and maintaining QMS in a regulated environment.
• Demonstrated leadership and people management skills, with experience guiding teams in lab safety and quality practices.
• Prior exposure to medical device testing environments, especially for AI-enabled or minimally invasive surgical systems will be an advantage.
• Proven experience in facility operations, EHS compliance, and quality system management.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills, with the ability to work effectively across technical, clinical, and regulatory stakeholders.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.