Quality Engineer II

Overview

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, including:
• 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 on hold (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) for design for manufacturing and 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 seamless knowledge transfer of projects and manufacturing processes;
• Support process validation or lead TMV; sustain Quality Engineering responsibilities such as review of Quality Metrics, Material Review Boards, and Quality Control;
• Prepare PMV, Process Validation plans;
• Assign support tasks; provide instruction to technicians on conducting tests; train technicians and provide feedback; coordinate technician work as needed;
• Perform other incidental duties assigned by Leadership.

• 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 to prevent injuries and protect the environment

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.

Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.

Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.