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Plant Quality Manager – Salt Lake City

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Salt Lake City, UT
$80,000 - $130,000
Job Type
Direct Hire
Bachelor of Science
Sep 27, 2018
Job ID
Plant Quality Manager – Salt Lake City
Our client is a leading developer, manufacturer, and global supplier of scientific labware products - (FDA plastics, glass, etc.). Only Change Managers need apply.  
Role Purpose:
Ensure that plant’s products meet customer requirements and directs, plan and implement plant policies and procedures relating to Quality consistent with Divisional and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements. Ensure that a quality system is established, implemented and maintained in accordance with ISO13485 and QSR CFR Title 21, Part 820.
Key Responsibilities
  • Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that the plant’s products meet all customer requirements.
  • Ensure regulatory compliance to all aspects of ISO13485 and 21 CFR 820 and all applicable regulations and guidance documents.
  • Review and acts as company representative for Quality and Supplier Agreement documents.
  • Leads the validation program and is responsible for risk management.
  • Responsible for all quality related training and handles the training program as it applies to cGMP and ISO requirements.
Travel Requirements:
  • Will travel 15% domestically or internationally.
Experiences/Education Required:
  • Bachelor’s degree in life sciences or engineering field.
  • Minimum of 8 years of related experience in quality.
  • 5+ years of manufacturing experience.
  • Successful supervisory, team leader and/or section supervisor experience in a manufacturing or quality function.
  • Demonstrated ability to get results within quality infrastructure.
  • Demonstrated leadership capability.
  • Expert familiarity with regulatory requirements including 21 CFR 820, ISO 13485 and ISO 14971.
  • Experience with quality management system software (i.e. ETQ, Lighthouse, Treckwise).
  • Knowledge of US and international pharmaceutical and medical device regulations.
  • ASQ (American Society of Quality) certification (or equivalent).
 Full relocation package. Excellent compensation package includes salary, benefits, bonus, and profit sharing.