Quality Specialist

3 weeks ago


San Ramon, United States Atlas Lift Tech Full time

POSITION OVERVIEW: The Quality Specialist will be expected to use training,

experience, and good judgement to perform tasks assigned in the Quality Department.


JOB RESPONSIBILITIES:

  • Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
  • Assist Complaint program at Atlas Lift Tech including tracking, trending, and updating associated metrics.
  • Completes Regulatory Risk Assessments related to Complaints.
  • Maintain the supplier activities and implementation of them into the Quality Management System. Review trends and data on suppliers and discuss with the
  • Quality manager any issues that need to be addressed.
  • Assist with Root Cause Analysis
  • Responsible for document control
  • Responsible for the revision, distribution and maintenance of controlled documents including Standard Operating Procedures, Work Instructions, Forms, specifications, and other miscellaneous documents.
  • Assist in preparation, submission, and maintenance of regulatory filing documents with the appropriate local, state, and federal agencies.
  • Responsible for maintaining controlled document libraries.
  • Coordinate requests for Change Orders, including preparing supporting documentation, communications, sample part review and scheduling for projects in engineering and quality.
  • Conducts process walks of procedures with other departments.
  • Contributes to team effort by accomplishing related tasks as needed. Will be required to perform other duties as required, directed, or assigned.


Education and Experience:

  • Thorough knowledge and minimum 3 years’ experience working in a regulated environment such as medical devices and experience with Quality Management
  • Systems and Medical Device Regulations: CFR 820, ISO 13485
  • Ability to prioritize and shift priorities quickly as needed.
  • Team-oriented with commitment to the success of the team and organizational goals to track.
  • Certification in Quality field preferred.
  • Experience working with manufacturing-based technology processes and principles preferred.
  • Must have good verbal and written communication skills.
  • Ability to multitask


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