Senior Quality Engineer

Edwards Lifesciences • Irvine, CA

7d • $108,000 - $153,000

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Quality Engineer position is a unique career opportunity that could be your next step towards an exciting future. This role is responsible to implement and integrate new technologies and processes within Irvine Implant Manufacturing working in collaboration with external stake holders at Implant Network Level. This role is responsible to provide Quality Engineering expertise to evaluate and qualify next generation equipment and/or automation in processes, define validation and regulatory strategies/requirements, lead/own validation and qualification activities, implement new process/system integration changes, and provide training to the stake holders. How You'll Make an Impact: 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; analyze results, make recommendations and develop reports. Identify and ensure the optimization of complex Manufacturing and/or R&D 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. Train, coach, and guide lower level employees on routine procedures

Requirements

• Bachelor’s degree in Engineering or a related field with 4 years of relevant industry experience
• Master’s degree with 3 years of related industry or industry/education experience.

Nice To Haves

• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• 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 inter-departmental teams and 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
• Experience in the medical device manufacturing and/or operations quality, automation, and process and test method validations is preferred.

Responsibilities

• 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; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
• Train, coach, and guide lower level employees on routine procedures

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level