Quality Manager in Costa Mesa, CA at Volt

Date Posted: 11/10/2020

Job Snapshot

Job Description

Direct Hire for a Quality Manager with a large Plastic Injection Molding company located in Costa Mesa CA

Ideal candidate will plan, establish, coordinate, and direct quality system designed to ensure compliance with ISO 13485/ ISO 9001 / AS9100 and FDA regulatory requirements.

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