Plant Quality Manager

3 days ago

Beaverton, Michigan, United States Saint-Gobain Full time
Job Summary

We are seeking a highly skilled Plant Quality Manager to join our team at Saint-Gobain Life Sciences. As a key member of our quality team, you will be responsible for ensuring the implementation of our Quality Management System and reporting areas of concern to management.

Key Responsibilities
  • Ensure the plant remains in full compliance with regulatory requirements and ISO 13485 standards.
  • Manage Quality department personnel, including Quality Lab, Supplier Quality, Quality Engineering, and Site Cleanroom Monitoring and Control.
  • Promote a safe working environment and comply with proper use of PPE.
  • Exhibit good environmental practices and procedures consistent with job functions and EMS requirements.
  • Execute and maintain ECO process, including change management and review of all change controls.
  • Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
  • Implement an effective Internal Audit Program and ensure adequate training program is in place.
  • Oversight of applicable Validation Master Plan, including equipment, process, product, sterilization, and test methods.
  • Review and approval of quality control testing and cleanroom practices, including qualification, monitoring, and behavior.
  • Responsibility for Quality Risk Management in relevant aspects of the QMS.
  • Maintenance and expansion of the Global QMS e-tool (ETQ) at the plant.
  • Facilitate management review process, including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System, and Supply Chain.
  • Oversight and Maintenance of Site Sterility Program and Customer Management, including facilitating/hosting customer audits and ensuring robust and effective corrective action to customer audit observations.
Requirements
  • Minimum Bachelor's Degree in Engineering or Life Sciences-related field (Chemistry, Biology, or Microbiology).
  • Master's Degree in MBA or equivalent preferred.
  • ASQ Certifications desirable (CQE, CQM, CQA) preferred.
  • Minimum of 8 years of experience in a regulated industry with emphasis in life sciences.
  • Minimum of 6 years in a Quality function with at least 3 years in a Quality System design, development, and implementation role.
  • At least 3 years in a direct supervisory role preferred.
  • Strong knowledge of ISO and cGXP requirements and relevant industry standard practices required.
  • Ability to interpret regulations to ensure proper implementation in plant systems required.
About Us

Saint-Gobain is a leading global producer of high-performance polymer products, improving lives by making simple experiences better and being there in life's critical moments. Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other.

We offer a comprehensive benefits package, including health and wellbeing, retirement and protection, and additional benefits. We are an equal opportunity employer, committed to diversity and inclusion, and support the hiring of veterans and individuals with disabilities.

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