Plant Quality Manager

Location: Salt Lake City, UT
This client is a leading developer, manufacturer, and global supplier of scientific labware products (FDA plastics, glassware, etc.). A new Plant Quality Manager is needed to ensure that plant products meet customer requirements; direct, plan and implement Quality Management policies and procedures that are consistent with Divisional and Corporate Quality/Regulatory programs and policies; and ensure that all Quality practices are in compliance with regulatory requirements, including 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 and internationally.
Experience and Education Requirements:
  • Bachelor’s degree in life sciences or a related engineering field.
  • Minimum of 8 years of related experience in Quality Management and/or Engineering.
  • 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).
Desired:
  • Knowledge of US and international pharmaceutical and medical device regulations.
  • ASQ (American Society of Quality) certification (or equivalent).
Growth opportunities for this position is superb and the company sponsors and promotes continuous development. The company also provides an excellent compensation program; excellent personal and family health and welfare benefits; performance bonuses; and profit sharing.

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