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Quality Engineer

1 month ago

Cleveland, United States GradBay Full time

Quality and Risk Engineer

Salary: up to $176k


This key role in the Quality organization involves leading Quality Engineering activities, providing technical support, coordinating documentation, and quality operations while ensuring compliance with established standards. Responsibilities include supervising and managing team duties according to organizational policies and applicable laws, focusing on continuous improvement, equipment/system upgrades, and cross-functional teamwork.

Key Responsibilities

  • Integrate Six Sigma methodology into validations and manufacturing processes.
  • Ensure compliance with software/hardware validation and data integrity requirements.
  • Support validation efforts and implement changes to specifications and SOPs.
  • Lead quality management teams and VIP projects.
  • Implement paperless systems and supervise area associates.
  • Train new engineers/associates and oversee training/cross-training.
  • Identify and implement improvements in laboratory testing methods and automation.
  • Lead qualification of upgrades and manage multiple tasks/projects.
  • Serve as a contact for quality software and validation with corporate or external interests.
  • Promote innovation and manage financial goals for departments.
  • Ensure compliance with environmental health and safety regulations.

Benefits

  • Medical, Dental, and Vision coverage from Day One.
  • 160 hours of Paid Time Off and Paid Holidays.
  • 401K match.
  • Paid Parental Leave.
  • Tuition Reimbursement.

Requirements

  • Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering.
  • 7+ years of experience in Quality, Manufacturing, Engineering, or related field, with 5+ years of leadership experience.
  • Thorough knowledge of applicable procedures, specifications, regulations, and standards.
  • Strong analytical, problem-solving, communication, and leadership skills.
  • Six Sigma Black Belt Certification or industry equivalent preferred.