Senior Engineer, Manufacturing Quality Assurance

Edwards Lifesciences (Singapore) Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global leader in innovative therapies seeks an experienced Quality Engineer in Singapore. In this role, you will investigate manufacturing quality issues, optimize processes using engineering methods, and develop technical content for risk management. Candidates should have a Bachelor's Degree in Engineering or a related field, with at least 4 years of experience. Strong problem-solving skills and the ability to work in a team are essential. This role requires adherence to quality systems and a proactive approach to safety and environmental protocols.

Qualifications

• 4 years min. experience in industry or related work experience required.
• 3 years min. experience for a Master's Degree or equivalent.
• No experience required for a Ph.D. or equivalent.

Responsibilities

• Investigate complex manufacturing product quality and compliance issues.
• Optimize Manufacturing/R&D processes using engineering methods.
• Develop and maintain technical content of risk management files.
• Create training and documentation materials for production.
• Assign tasks and instruct technicians in test conducting.
• Train and guide lower level employees on procedures.

Skills

MS Office Suite

Strong communication skills

Statistical techniques

Problem-solving skills

Leadership skills

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

CAD

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non‑conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work
• Train, coach, and guide lower level employees on routine procedures
• Other Incidental Duties

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 4 years min. experience in industry or industry/education related work experience Required
• Master's Degree or equivalent in Engineering or Scientific field, 3 years min. experience in industry or industry/education related work experience Required
• Ph.D. or equivalent in Engineering or Scientific field no experience Required

What else we look for (Preferred):

• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem‑solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter‑departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control