Transform lives with innovative quality engineering.
Detailed Role Description
You will be a key member of our Quality team, influencing the development of pioneering technologies to ensure every stage of our innovation process meets the highest standards of excellence and safety.
You will collaborate with various teams to shape decision-making for a product's entire lifecycle, optimizing product development to impact patients worldwide with groundbreaking technology.
The role involves applying advanced 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.
Main Responsibilities:
* Design and execute complex experiments and tests (including writing and executing protocols) to create, validate, and improve products and manufacturing processes/methods based on engineering principles.
* Analyse results, make recommendations, and develop comprehensive reports.
* 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.
* Analyse results, make recommendations, and develop reports.
* Optimize complex Manufacturing processes using advanced 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; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.
Key Requirements:
* Bachelor's Degree in Engineering or scientific field required.
* At least 2 years of relevant experience in a similar role.
* Excellent computer skills in usage of MS Office Suite; CAD experience preferred.
* Strong documentation, communication, and interpersonal relationship skills.
* Familiarity with statistical techniques.
* Prior experience working with lab/industrial equipment preferred.
* In-depth understanding of principles, theories, and concepts relevant to Engineering.
* Superior problem-solving, organizational, analytical, and critical thinking skills.
* Understanding of processes and equipment used in assigned work.
* Knowledge of and adherence to Quality systems.
* Straight attention to detail.
* Able to interact professionally with all organisational levels.
* Able 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.
* Able to build stable working relationships internally.
* Able to 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.