Senior Quality Engineer

Innovation starts from the heart. Edwards Lifesciences i 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 Senior Quality Engineer position is a unique career opportunity that could be your next step towards an exciting future.

This is an exciting opportunity within our Irvine Implant Manufacturing Plant in Quality Engineering to support the PURA Project for the process development and manufacturing of Edwards' next-generation tissue technology for heart valves.  The Quality Engineer will be a key member of a cross-functional core team responsible for supplier quality and process development deliverables for the project. In this role, the engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards’ systems’ procedures while optimizing engineering activities from new product introduction, continuous improvement, process development, validation activities and Manufacturing Execution System (MES).

How You'll Make an Impact:

• Identify and ensure the optimization of Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.

• Identify opportunities for re-design/design of basic equipment, tools, fixtures, MES, etc. to improve manufacturing processes, and reduce risk.

• Develop, update, and maintain technical content of risk management files.

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

• Support and lead Process Validation on Manufacturing Equipment (IQ/OQ/PQ) through review and approval of protocols and reports.

• Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities to support Tissue & Solutions Operations projects and activities.

• Update, and maintain supplier file content including Supplier Management system administration, support Approved Supplier List (ASL) activities, and any required Preference Category status changes.

• Own and coordinate supplier Notice of Change (NOC) requests. Manage supplier project plans, facilitate part qualification process, and ensure closure of any change plan deliverables.

• Partner with Supplier Management to onboard new suppliers in alignment with each category strategy. Activities include developing and finalizing Quality Agreements, supporting Technical Assessment, Supplier Management system administration (SQMS), and conducting the initial qualification audits.
  Train, coach, and guide lower level employees on routine procedures.

• Support the Quality Audit program for all identified suppliers (Surveillance, Qualification, Performance), which includes conducting the Quality Audit, drive corrective actions, and ensure closure of any findings.

• Support Edwards sites in their Receive on Certification program owning supplier agreements, SPC data reviews, and process audits, where appropriate.

• Perform other duties and responsibilities as assigned.

What You'll Need (Required):

• Bachelor's Degree in Engineering with 4 years experience in Medical Device industry Required or

• Master's Degree or equivalent in Engineering with 3 years experience in Medical Device industry Required.

What Else We Look For (Preferred):

• 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

• Previous experience working with lab/industrial equipment required

• 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 environ