Senior Quality Engineer – Sheaths

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

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Quality Engineer to ensure regulatory compliance and robust product development across the lifecycle. You will apply quality engineering principles to manufacturing, design controls, and distribution, collaborating with cross-functional teams to drive improvements and risk reduction.

Responsibilities include investigating manufacturing quality issues, managing NCRs/CAPAs/ECRs and audits, supporting external audits, and developing risk management

Qualifications

• Bachelor's degree in Engineering or related field with 4+ years of experience in the industry.
• Master's degree or equivalent with 3+ years of experience; Ph.D. with 0+ years acceptable.
• Certifications CQE, Six Sigma or Lean Blackbelt preferred.
• Strong documentation and communication skills, with ability to interact across levels.

Responsibilities

• Investigate complex manufacturing quality and compliance issues.
• Manage site NCRs, CAPA, ECRs, and audit observations for production processes.
• Provide support for internal and external audits.
• Lead process improvement using Six Sigma/LEAN methods for design and manufacturing.
• Develop, update, and maintain risk management files and pFMEAs with the BU PMS team.
• Develop training materials and work instructions for production.

Skills

Quality engineering

Six Sigma

LEAN

Root cause analysis

Process improvement

Documentation

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Ph.D. in Engineering

Tools

MS Office Suite

pFMEA

CAPA systems

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). 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.