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.  

In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:  

• Investigate basic 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 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.

• May 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 coordinates technician work.

• Other incidental duties assigned by Leadership.

What you'll need:

• Bachelor's Degree in Engineering or scientific field with 2 years engineering experience.

What else we look for:

• Knowledge of and adherence to Quality systems.

• Good computer skills in usage of MS Office Suite; CAD experience preferred
  Basic documentation, communication and interpersonal relationship skills.

• Basic understanding of statistical techniques.
  Previous experience working with lab/industrial equipment.

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

• Good problem-solving, organizational, analytical and critical thinking skills.

• Good understanding of processes and equipment used in assigned work.

• Ability to interact professionally with all organizational levels.

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

• Ability to build stable working relationships internally.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.