Quality Engineer I

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of ground-breaking 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.

The Quality Engineer I Applies 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'll make an impact:

• Investigate basic manufacturing product quality and compliance issues which may include:

  • Investigate PRAs and complaints for manufacturing related issues

  • Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results,

  • Provide technical support to external land internal audits,

  • Make recommendations and develop reports.

• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control.

• Review and approve equipment validations and asset management actions.

• Optimize 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.

• Collaborate with engineering teams to ensure successful transfers

• May develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

• Provides support to the following:

  • Process validation or support/lead TMV

  • Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc

  • PMV, Process Validation plans

• 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 (Required):

• Bachelor's Degree in an Engineering or Scientific field and a minimum of 1 years experience in a similar role required

What else we look for (Preferred):

• 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 preferred

• 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

• 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 immediate supervisor and other team members in the section or group

• Ability to build stable working relationships internally

• 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