Principal Quality Engineer

Edwards Lifesciences Gruppe; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

Edwards Lifesciences in Ireland seeks a Quality Engineer to provide engineering expertise ensuring regulatory compliance and optimize product development, manufacturing and distribution.

You will lead investigation of manufacturing quality issues, train staff, oversee QA tasks, drive development of tests and validation, and apply Six Sigma and Lean for continuous improvement across devices.

Qualifications

• Bachelor's degree in Engineering or Science is required.
• At least 6 years of related experience.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead investigation of manufacturing quality and compliance issues.
• Coach and guide engineers and technicians on procedures.
• Oversee QA tasks and coordinate tests and data reviews.
• Drive development and execution of experiments to improve processes.
• Apply Six Sigma and Lean for process optimization.
• Develop training and work instructions for production.

Skills

Quality engineering

Six Sigma

Lean methods

Regulatory compliance

Leadership

Problem solving

Communication

Education

Bachelor's degree in Engineering or Scientific field

Tools

MS Office Suite

Job description

Make a meaningful difference to patients around the world. Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking 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 optimising product development to impact patients around the world with pioneering technology.

The Role

Provide engineering expertise to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How Will You Make An Impact?

• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyse results, make recommendations and develop reports
• Train, coach, and guide lower level employees on more complex procedures and direct activities that support broader projects and/or initiatives
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyse results, make recommendations, and develop reports and collaborate with team members to drive project completion
• Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement
• Independently create initial design concept and lead the process in the re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Oversee and approve technical content of risk management files and ensure it aligns to global procedures; Define validation and risk management strategies and ensure appropriate implementation of risk control
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless (effective) knowledge transfer of project and manufacturing processes

What You’ll Need?

Bachelor's Degree in Engineering or Scientific field

Minimum of 6 years experience Required

What Else We Look For?

• Proven expertise in usage of MS Office Suite and related systems and programs
• Ability to read and interpret drawings
• Proven expertise in statistical techniques
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate technical information to all levels of the organizations
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
• Knowledge of Six Sigma concepts with ability to apply to work product
• Knowledge of Quality Engineering concepts with ability to apply to work product
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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 frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• 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 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.