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Senior Manufacturing Quality Engineer

4 months ago

Bothell, United States Career Management Group Full time

As a Senior Manufacturing Quality Engineer, you are responsible for identifying and supporting continuous improvement as it relates to manufacturing transfer and daily production. The ideal candidate will be an adequate problem-solver who is confident implementing appropriate changes and should be comfortable working closely with multiple departments.


QUALIFICATIONS

  • 7+ years of experience or equivalent experience in Medical Device manufacturing and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601.
  • Bachelor’s degree in engineering or life science discipline
  • Experience with manufacturing transfer, process validation and sustaining of mechanical and software driven devices.
  • Experience with process risk management creation and maintenance.
  • Experience with test method development and the validation of those test methods.
  • Experience with the development and implementation of inspection plans.
  • Strong technical ability using computational tools and electronic QMS.
  • Ability to quickly learn new applications, tools, and concepts.
  • strong work ethic and an ability to excel in a flexible and fast-paced work environment.
  • Ability to provide guidance and mentorship of good quality principles and practices.
  • Excellent written/oral communication skills required.


PREFERRED EDUCATION/SKILLS

  • Master’s degree in engineering or life science discipline
  • Must be able to work effectively with diverse groups of people.
  • Six Sigma (DMAIC)
  • Lean


DUTIES AND ESSENTIAL FUNCTIONS

Each employee consistently demonstrates the following essential functions:

  • Metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, NC, and change management.
  • Ability to review and approve changes to currently commercialized product regarding the process risk management of the product.
  • Applies statistics to make business decisions.
  • Ability to conduct failure investigation and root cause analysis.
  • Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
  • Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
  • Attends and participates in departmental meetings.
  • Attends seminars and training sessions necessary to maintain.
  • appropriate level of professional competence.
  • Ensures all department compliance guidelines are met.
  • Attends all meetings, in-services training, or continuing education as delegated by the supervisor.
  • Provides customer focused interactions.
  • Performs all duties necessary for the department as per department policies and procedures.
  • Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.