Senior Engineer, Quality

As a Manufacturing Sustaining Senior Quality Engineer, you'll support 1st shift of Irvine Implant Manufacturing's valve operations across RESILIA processing, sterilization, and packaging. You'll apply quality engineering principles to keep our systems and procedures compliant with regulatory requirements while optimizing product development, device manufacturing, and distribution.

• Investigate complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) across all production processes prior to final product release; analyze results, make recommendations, and develop reports.

• Optimize complex manufacturing processes using quality engineering methods (e.g., Six Sigma and Lean) to drive design for manufacturing and continuous process improvement.

• Identify opportunities to design or re-design equipment, tools, and fixtures that improve manufacturing processes and reduce risk.

• Develop, update, and maintain the technical content of risk management files.

• Create training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.

• Assign support tasks and provide direction to technicians on conducting tests; train, coach, and provide feedback; and coordinate technician work.

• Train, coach, and guide lower-level employees on routine procedures.

What else we look for (Preferred):

• Substantial understanding of the principles, theories, and concepts relevant to Quality Engineering

• Knowledge of and adherence to Quality systems

• Working knowledge of statistical techniques

• Strong documentation, communication, and interpersonal skills, including negotiation and relationship management

• Prior experience working with laboratory or industrial equipment

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

• Substantial understanding of the processes and equipment used in assigned work

• Solid leadership skills and the ability to influence change

• Proven proficiency with MS Office Suite

• Strict attention to detail

• Ability to manage competing priorities in a fast-paced environment

• Ability to interact professionally across all organizational levels

• Ability to work effectively in a team environment, including inter-departmental teams, and serve as a 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

• Travel for this position can be up to 5%