Quality Engineer Manager - Pilot Operations

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 Edwards’ innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for team leadership, problem solving and partner with various teams to influence decision-making for products’ entire life cycles.

Your work will enable you to optimize product development to impact patients around the world with pioneering technology.

This position will lead the Pilot Quality Operations function for TMTT and AIT programs as part of Global Supply Chain Pilot Manufacturing in Irvine. This position will lead a team of Pilot QEs that work with new product development teams in the manufacturing of products for feasibility/design verification studies, first-in-human/clinical builds and limited volume commercial manufacturing. This role also supports the product transfer from the Pilot Operations into commercial manufacturing facilities.

How you will make an impact:

Direct supervision and development of a group of Quality Engineers. Oversee engineering tasks
-provide technical guidance and feedback to engineers. Guide lower-level employees on complex procedures. Work on complex issues where analysis of issues requires in-depth knowledge.

Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables. Oversee the development of project plans and timelines, identify risks and develop contingency plans to meet project objectives.

Lead test method validation activities and Process FMEAs for Pilot Manufacturing lines. Support IQ/OQ/PQ for manufacturing equipment on the Pilot lines.

Collaboration with R&D/NPD (New Product Development) to identify DFM opportunities and develop process/inspection characterization strategies. Partner with Commercial Operations and NPD to implement and sustain best practices across the manufacturing network.

Identify opportunities and lead the implementation of changes to drive improvements in the development of robust processes that assure quality products and services. Track performance and perform quality trend analysis to drive continuous improvement.

Drive Implementation of Critical Control Points on Pilot product manufacturing lines consistent with Edwards CCP methodology.

Responsible for the decision of release/rejection/disposition of all products manufactured as part of the Pilot Manufacturing lines. Address product and process deficiencies through non-conformance and CAPA reports.

Support product transfer from Pilot to commercial manufacturing sites.

What you'll need (Required):

Bachelor's Degree in related field related experience in engineering

Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry

What else we look for (Preferred):

Experience working in a regulated industry

Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills

Proven successful project management skills

Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Engineering experience with medical devices and/or delivery systems

People leadership for teams of 3+ direct reports

Technical expertise in process development, statistics and/or software development/validation

Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods

Strict attention to detail

Deep knowledge and experience using Lean and 6-sigma tools, Black Belt, preferred

Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

Develop relationships and leverage them to influence change

Support and solicit input from team members at all levels within the…