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 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. In this role, you will apply your 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.
How you will make an impact:
Investigate complex manufacturing product quality and compliance issues which may include:
Investigating PRAs and complaints for manufacturing related issues
Managing site NCRs, CAPA, ECRs, and audit observations for all production processes prior to final product release based on engineering principles
Providing technical support to external and internal audits
Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
Oversee product release, assess and disposition product on hold (MRB), and manage material quality control, manufacturing / process changes (not related to design).
Review and approve equipment validations and asset management actions.
Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Provide lead and guidance to the following:
Support process validation or support/lead TMV
Lead sustaining Quality Engineering responsibilities such as, review Quality Metrics, Material Review Boards, Quality control etc
Lead TMV, Process Validation plans
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Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train, coach, and guide lower level employees on routine procedures.
Other incidental duties assigned by Leadership
What you'll need (Required):
Bachelor's Degree in Engineering or related field, 4 years’ experience related industry experience or
Master's Degree or equivalent in Engineering or related field, 3 years’ experience related industry experience or
Ph.D. or equivalent in Engineering or related field, 0 years’ experience related industry experience
What else we look for (Preferred):
Certifications CQE (Certified Quality Engineer), Six Sigma or Lean Blackbelt
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 will be required for work related plant sites
Previous experience working with lab/industrial equipment
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 environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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