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QA Associate II

VC Funded Stealth Startup

This is a Full-time position in vacaville, CA posted January 3, 2023.



We’re seeking a QA Associate to provide support to all functions within the Quality department. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to support NIOSH N95 respirator qualification and N95 respirator production. The associate will be charged with assisting in the development of the Quality Management System that safeguards product quality and fosters a culture in which all employees are actively engaged.

Responsibilities:

  • Support our NIOSH N95 respirator certification process
  • Assist in the development of our Quality Management System by writing, reviewing and updating Quality Documents
  • Administer the Document Control system including documentation and tracking of requests, approvals and implementation
  • Maintain master documents and records, training records, audit files and raw data
  • Execute QA operations required to assess, evaluate, and review operations on the production floor and to assure real-time observation of activities, issue identification and resolution including proper and timely documentation
  • Perform review and approval of documentation, deviations and CAPAs in support of batch disposition
  • Perform product batch disposition
  • Work closely with other departments to develop and facilitate actions to manage the systems for Change Control, CAPA, Deviations, Complaints and Internal Audits
  • Utilize quality tools and techniques to perform and document root cause analysis investigations, to evaluate and resolve quality issues, and to enhance continuous improvement
  • Perform investigations of NCMRs and product quality complaints to eliminate the root cause of non-conformances
  • Perform training and support that covers policies, procedures and core processes

Education:

  • Bachelors Degree preferred or equivalent work, training and experience

Experience:

  • Minimum 3+ years in Quality Assurance in a production/manufacturing environment
  • Experience utilizing Quality System processes (Deviation, CAPA, Change Control, Audit)
  • Familiarity with ISO9001, 15013485 QMS and NIOSH knowledge a plus
  • Knowledge of IQ/OQ/PQ protocols and Continuous Improvement techniques
  • Familiarity with basic measuring and QA/OC tools and methods

Skills Required/Desired:

Required:

  • Good Documentation Practices (GDPs) and reporting skills
  • Excellent written and verbal communication skills
  • Ability to work independently
  • Excellent problem-solving, analytical skills and decision-making skills
  • Strong attention to detail
  • Deep knowledge of quality assurance terminology, methods and tools
  • Microsoft Office skills
  • Ability to prioritize and manage several projects and activities simultaneously
  • Teamwork and collaboration
  • Authorized to work in the U.S. with the ability to pass a D.O.D. background check

Desired:

  • Strong technical writing/editing skills
  • Proficiency in database management
  • Experience with Regulatory inspections with the ability to act as a Subject Matter Expert
  • Demonstrates positive attitude, strong work ethic, and self-motivation
  • Fast learner, able to react quickly in a fast-paced environment
  • Customer Service/Quality Driven
  • Knowledge of ISO9001, ISO13485 and NIOSH standards