Senior Quality Engineer (QMS)

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 optimizing product development to impact patients around the world with pioneering technology.

How you will 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; analyze results, make recommendations and develop reports

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; analyze 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. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Develop 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

Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Train, coach, and guide lower level employees on more complex procedures

What you’ll need (Required):

Bachelor's Degree in Engineering or Scientific field

5 years of experience in Quality Management Systems

Certified auditor

What else we look for (Preferred):

American Association of Lab. Animal Sci. Cert. (AALAS) / ASQ Certified Quality Engineer (CQE)

Proven expertise in usage of MS Office Suite

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 and knowledge 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

Work is performed independently while exercising considerable latitude in making
significant decisions

Set policies and standards that are followed by others

Guides others in resolving basic issues in specialized area based on existing solutions and procedures

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

Develops technical solutions to complex problems which require the regular use of
creativity

Uses best practices and knowledge of internal or external business issues to improve
products/services or processes

Typically resolves complex problems or problems where precedent may not exist

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