Quality Manager in Costa Mesa, CA at Volt

Date Posted: 8/23/2021

Job Snapshot

Job Description

Direct Hire for a Quality Manager with a large Plastic Injection Molding company located in Irvine, CA

Ideal candidate should have experience and be comfortable being present on the manufacturing floor, reviewing the work being done, and training the inspectors/technicians where needed.

Responsibilities

  • Implements the company Quality Management System. Measures and monitors performance for compliance and reports performance to management. Drives improvements efforts for the entire quality system.
  • Has detailed knowledge of Reference ISO 9001 / AS9100 / ISO 13485 documentation and acts as Management Representative for controlling authorities.
  • Ensure compliance to internal and external ISO 9001 / AS9100 / ISO 13485 policies and requirements.
  • Creates and implements policies, inspection criteria and procedures.
  • Manages and directs medical device record keeping (DHR) per applicable procedures and standards.
  • Oversees product evaluation/measurement required for mold and equipment validations.
  • Provides inspection activity for product throughout the production cycle.
  • Applies total quality management tools and approaches to analytical and reporting process within each department.
  • Engage inspection and testing activities to ensure continuous control over products.
  • Design and implements company quality training programs to key personnel in conjunction with Supervisors.
  • Must adhere to FDA and ITAR regulations as required.

Qualifications

  • Bachelor’ s Degree or equivalent combination of training and job experience
  • Must have experience implementing, certifying and maintaining an ISO 13485 quality system (AS9100/ ISO 9001 experience is desirable)
  • Must be familiar with clean room procedures, medical device DHR procedures and GMP/GDP standards.
  • Experience in plastic manufacturing helpful but not required
  • Experience with IQMS or equivalent enterprise software package is a definite plus.
  • Must be competent in the use of common PC programs and QA software packages (including Microsoft Word, Excel, PowerPoint, MiniTab)

Volt is an equal opportunity employer