Engineer II (Quality)
Orange County Metro Area, CA
Life Sciences Industry
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and our systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.
- 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 to 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, 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; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Bachelor's Degree or equivalent in Engineering or Scientific field with 2 years related work experience
- Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
- 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 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 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
- Works independently without close supervision
- Compares and evaluates possible courses of action after considering various possibilities
- Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met
- Considers the cause and effect of activities
- Determines or effectively recommends course of action after considering potential risks of alternatives
- May provide guidance to lower level personnel
- Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment