CAREER OPPORTUNITIES

QA Associate

Richmond, CA
Posted 2 months ago

Performs a variety of tasks necessary to implement and maintain the Quality Management System including product complaint/feedback, document and record control, internal/external audits, equipment calibration/maintenance, training, product design, and corrective actions. Supports commitment to quality and trains other department personnel on QMS processes and procedures. Responsible for maintaining the safety program including training.

Primary Job Duties

Quality System

  • Assists the Quality Manager with the maintenance and implementation of QMS processes and procedures.
  • Interprets and implements quality assurance standards and OSHA safety standards.
  • Develops and writes QMS documents and procedures for approval by the Quality Manager.
  • Conducts internal audits, evaluates findings and implements appropriate corrective actions.
  • Prepares for and participates in external audits and responds to issues.
  • Responsible for facility document control program.
  • Responsible for the maintenance of the facility maintenance and calibration program.
  • Investigates customer complaints and customer feedback.
  • Participates in the product design process for new products.
  • Analyzes quality data and logs to identify anomalies and trends.
  • Assists the Quality Manager with the maintenance and implementation of Safety Program.
  • Maintains database on required training, needs and participants.
  • Utilizes computer and software necessary for the development of documents and recording of Quality records and data.

Supporting Functions

  • Maintains accurate and complete documentation of all work performed for the establishment of methods and standards.
  • Conducts training programs for Quality and in the use of quality processes and tools.
  • Conducts training for safety programs.
  • Creates QSR reports for review by management.
  • Maintains and reviews maintenance and calibration schedules for Quality Control and Applications equipment.
  • Responsible for pipet calibration/verification program.
  • Maintains inventories of master lots/testing materials for Quality Control.
  • Maintains product retain system.
  • Assists other departments with procedure development and writing.

Position Requirements

  • A bachelor’s degree in a life sciences or related discipline and three years of related work experience which includes quality assurance experience preferably in the chemical or diagnostic industry, OR a combination of education and applicable work experience.
  • Previous related work experience that provides the knowledge of and skill for technical writing.
  • Good written and verbal communication skills
  • Good planning and organizational skills and the ability to work independently.
  • Good understanding of General Manufacturing Practices in the medical device industry.
  • Requires the ability to work on more than one ongoing project at one time.
  • Knowledge of ISO requirements and audits.
  • Knowledge of OSHA safety standards.

Experience

  • ISO Audits and Requirements: 2 years (Preferred)
  • Laboratory: 2 years (Preferred)
  • Quality Assurance: 2 years (Preferred)

Education

  • Bachelor’s (Preferred)

Job Type

  • Full-Time

Job Features

Job CategoryQA/RA

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