Senior Quality Engineer – Sheaths

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Quality Engineer to apply quality engineering principles across product development, internal/external manufacturing, and distribution. You will help ensure regulatory compliance and uphold our safety standards for patient outcomes.

You will lead investigations, CAPAs, and process improvements, collaborating with cross‑functional teams to drive risk management and continuous quality improvements. A CQE or Lean Six Sigma background is preferred.

Qualifications

• Bachelor's degree in Engineering or related field with 4 years’ experience in the industry
• Master's degree or equivalent in Engineering or related field with 3 years’ experience
• Ph.D. or equivalent in Engineering or related field

Responsibilities

• Investigate manufacturing quality and compliance issues including PRAs and complaints
• Manage site NCRs, CAPA, ECRs and audit observations for production processes
• Provide technical support to external and internal audits
• Identify and optimize complex manufacturing processes using Six Sigma/LEAN
• Oversee product release and disposition of material on hold (MRB)
• Review and approve equipment validations and asset management actions
• Develop risk management content and update pFMEAs with cross‑functional teams

Skills

Quality engineering

Regulatory compliance

Statistical methods

Leadership

Problem solving

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Ph.D. in Engineering

Tools

MS Office Suite

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality team helps 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 complex manufacturing product quality and compliance issues which may include:
  • Investigating PRAs and complaints for manufacturing related issues
  • Managing site NCRs, CAPA, ECRs, and audit observations for all production processes prior to final product release based on engineering principles
  • Providing technical support to external and internal audits
• Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP 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.
• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control, manufacturing / process changes (not related to design).
• Review and approve equipment validations and asset management actions.
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Provide lead and guidance to the following:
  • Support process validation or support/lead TMV
  • Lead sustaining Quality Engineering responsibilities such as, review Quality Metrics, Material Review Boards, Quality control etc
  • Lead TMV, Process Validation plans
• 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.
• Other incidental duties assigned by Leadership

What you’ll need (Required):

• Bachelor's Degree in Engineering or related field, 4 years’ experience related industry experience or
• Master's Degree or equivalent in Engineering or related field, 3 years’ experience related industry experience or
• Ph.D. or equivalent in Engineering or related field, 0 years’ experience related industry experience

What else we look for (Preferred):

• Certifications CQE (Certified Quality Engineer), Six Sigma or Lean Blackbelt
• Proven expertise in usage of MS Office Suite
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques will be required for work related plant sites
• Previous experience working with lab/industrial equipment
• 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

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 $108,000 to $153,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.