Quality Control Technician II - Medical Device (Cool Sculpting)

Allergan, Inc. Dublin , CA 94568

Posted 3 weeks ago

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

This role is responsible for the inspection and release of all incoming materials and final product. This includes the review of records, inspection of materials and product compliance with specifications and procedures.

Main Areas of Responsibilities

  • Perform visual, functional and dimensional testing on incoming materials

  • Inspect and verify the product and documentation to release final product for shipment

  • Identify and record product or documentation quality issues

  • Issue nonconformance reports as necessary and work with quality engineers on resolution

  • Audit manufacturing line, work stations and quarantine areas to ensure compliance to requirements.

  • Inspect in-process subassemblies

  • Assist in maintenance and coordination of calibration system

  • Scanning DHR's

  • Travel between Allergan locations

Preferred Skills/Qualifications

  • Must be available to work overtime as requested by the supervisor. This may include nights, weekends, and holidays during times critical to our business such as month-end, quarter-end, and year-end.

  • Perform additional tasks assigned by supervisor

Requirements

  • At least 2 years of experience in quality inspection/release, preferably in an FDA regulated industry

  • Experience with common measurement and testing tools and equipment

  • Electromechanical device experience a plus

  • Able to read and understand Device History Records, specifications and reports

  • Responsible for performing all duties in compliance with FDA Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Allergan complies.

  • Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

  • Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

Education

  • High school diploma or equivalent
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