Quality Engineer II

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 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; analyze 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 continuous process improvement. Identify opportunities for redesign/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 transfer of knowledge for project and manufacturing processes.

• Assign support tasks; give instructions to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.

• Perform other incidental duties as assigned by leadership.

What you will need (Required):

• Bachelor's degree in Engineering or a scientific field and 2 years of experience.

• Master's degree or equivalent, and internship, senior project or thesis experience in Engineering or a scientific field, including either industry or industry/education experience.

What else we look for (Preferred):

• CQE (Certified Quality Engineer), if applicable

• Good documentation, communication and interpersonal relationship skills, including negotiating and relationship management skills.

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment is required.

• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Solid problem-solving, organizational, analytical and critical thinking skills

• Solid 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 organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Ability to build productive internal/external working relationships

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures to prevent injuries to themselves and others, as well as protect the environment and prevent pollution under their span of influence/control.

• Digital skills in Artificial Intelligence, Power BI and data analysis.

• Leadership skills