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Quality Engineer I Jobs

Company

Edwards Lifesciences

Address Salt Lake City, UT, United States
Employment type FULL_TIME
Salary
Category Medical Equipment Manufacturing
Expires 2023-05-16
Posted at 1 year ago
Job Description
This is an exciting opportunity for a Quality Engineer to join our team at our Draper, Utah site supporting the sustaining activities for our balloons and extrusions commercial production. They will apply 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.
Key Responsibilities:
  • Other incidental duties assigned by Leadership
  • Optimize 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 basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
  • May develop, update, and maintain technical content of risk management files
  • Investigate basic manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinates technician work
Required Qualifications:
  • Bachelor's Degree in an Engineering or scientific field required OR
  • Master's Degree or equivalent in an Engineering or scientific field required
Preferred Qualifications:
  • Strict attention to detail
  • 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
  • Ability to manage competing priorities in a fast paced environment
  • Basic understanding of statistical techniques
  • Must be able to work in a team environment
  • Knowledge of and adherence to Quality systems
  • Good understanding of processes and equipment used in assigned work
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Good computer skills in usage of MS Office Suite; CAD experience
  • Basic documentation, communication and interpersonal relationship skills
  • Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Ability to interact professionally with all organizational levels
  • Previous experience working with lab/industrial equipment
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.