Quality Specialist II

3 weeks ago


San Ramon, United States Atlas Lift Tech Full time

Quality Specialist

Are you a detail-oriented quality professional with a passion for ensuring excellence?

Atlas Lift Tech is seeking a Quality Specialist to support our commitment to delivering top-quality products and services. In this role, you will play a critical part in maintaining compliance with industry standards and regulations.


Responsibilities:

  • Initiate and manage quality-related processes including deviations, CAPAs, and change control.
  • Contribute to the complaint program by tracking, trending, and completing regulatory risk assessments.
  • Oversee supplier quality activities and maintain relevant documentation.
  • Conduct root cause analysis and support continuous improvement initiatives.
  • Manage document control, including creation, revision, and distribution of controlled documents.
  • Assist with regulatory filings and maintain controlled document libraries.
  • Coordinate change orders and conduct process walks.
  • Collaborate with cross-functional teams to achieve quality objectives.

Qualifications:

  • Bachelor's degree required with a minimum of 3 years of experience in a regulated environment (medical devices preferred).
  • Strong understanding of Quality Management Systems (QMS) and Medical Device Regulations (CFR 820, ISO 13485).
  • Excellent attention to detail and organizational skills.
  • Ability to prioritize tasks and meet deadlines.
  • Strong written and verbal communication skills.
  • Proficiency in relevant software applications.
  • Quality certification (preferred).


Ready to make a difference?  Join our team and enjoy a challenging and rewarding career opportunity.

We offer a competitive compensation package, including benefits and opportunities for professional growth.


Keywords: Quality Specialist, Quality Assurance, Quality Control, Regulatory Affairs, Medical Devices, QMS, ISO 13485, CFR 820, CAPA, Change Control, Document Control, Root Cause Analysis, Supplier Quality



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