Be a part of shaping ground-breaking technologies that change patient's lives. Our Quality teams play a vital role in the innovation process, ensuring each stage meets the highest standards of integrity and safety.
You'll bring your passion for problem-solving and partner with various teams to influence decision-making throughout a product's lifecycle. Your work will involve optimizing product development to impact patients worldwide with pioneering technology.
The Role:
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities:
- Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products and manufacturing processes based on engineering principles; analyse results, make recommendations, and develop reports.
- Develop, update, and maintain technical content of risk management files.
- Investigate moderately 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; analyse results, make recommendations, and develop reports.
- Optimize moderately complex Manufacturing 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 training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Requirements:
- Minimum Bachelor's Degree in Engineering or scientific field.
- 2+ years of relevant experience in a similar role.
Desirable Skills:
- Good computer skills in usage of MS Office Suite; CAD experience preferred.
- Basic documentation, communication, and interpersonal relationship skills.
- Basic understanding of statistical techniques.
- Previous experience working with lab/industrial equipment preferred.
- Good understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Good problem-solving, organizational, analytical, and critical thinking skills.
- Good understanding of processes and equipment used in assigned work.
- Knowledge of and adherence to Quality systems.
- Strict attention to detail.
- Ability to interact professionally with all organisational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including immediate supervisor and other team members in the section or group.
- Ability to build stable working relationships internally.
- Adhere to all company rules and requirements 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.