Senior Quality Engineer – Sheaths

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.

• Investigate complex manufacturing product quality and compliance issues which may include:
  • Investigating PRAs and complaints for manufacturing related issues
  • Managing site NCRs, CAPAs, 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 redesign/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 reviewing Quality Metrics, Material Review Boards, Quality control, etc.
  • Lead TMV, Process Validation plans
• Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.
• Train, coach, and guide lower level employees on routine procedures.
• Other incidental duties assigned by Leadership.

• 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

• 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…