Quality Engineer II

Overview

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Engineer II position is a unique career opportunity that could be your next step towards an exciting future.

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.

• Investigate moderately complex 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 and internal audits
• Make recommendations and develop reports
• Oversee product release, assess and disposition product onhold (MRB), and manage material quality control
• Review and approve equipment validations and asset management actions
• Optimize moderately complex manufacturing processes using engineering methods (e.g., SIX Sigma, TOPS, and LEAN methods) for design for manufacturing and for continuous process improvement; identify opportunities for redesign of basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk
• Collaborate with engineering teams to ensure successful transfers
• 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
• Provide support to process validation or lead TMV; sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control, etc.
• PMV, Process Validation plans
• Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work
• Other incidental duties assigned by Leadership

• What You'll Need (Required): Bachelor’s degree in an Engineering or Scientific field with 2 years of related experience, or a Master’s degree with relevant internship, senior project, or thesis experience

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid 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 the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• 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

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

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.