Quality Excellence Director

2 weeks ago


Allentown, Pennsylvania, United States Joulé Full time

Job Description:

Joulé is seeking an experienced Quality Excellence Director to lead our site Quality Engineering and Customer Complaint teams within GMP manufacturing of medical devices. As a strategic leader, you will drive quality excellence by leveraging quality metrics, CAPA processes, and risk management to identify and resolve quality issues proactively.

About the Role:

The ideal candidate will have a strong background in GMP Quality and/or Medical Device Manufacturing, with experience in overseeing customer complaint investigations, CAPAs, and quality metrics. You will also mentor and grow team members, empowering them to reach new heights.

Key Responsibilities:

  • Lead site Quality Engineering and Customer Complaint teams within GMP manufacturing of medical devices
  • Develop and implement quality metrics and CAPA processes to drive quality excellence
  • Conduct risk management activities and implement strategies to identify and mitigate quality issues
  • Manage and lead a team of quality engineers and technicians
  • Collaborate with cross-functional teams to ensure quality and regulatory compliance

Requirements:

  • Background in GMP Quality and/or Medical Device Manufacturing
  • ASQ Certified Quality Engineering (CQE) or similar certification
  • Six Sigma green belt or problem-solving training (DMAIC) preferred
  • Expertise in basic statistical tools, mechanical aptitude, and methodical problem-solving
  • Strong communication and leadership skills
  • Knowledge of root cause analysis, quality tools, and post market risk management
  • Mechanical aptitude skills for device building and test set-ups
  • Knowledge of statistical tools and their targeted application to medical device post market surveillance
  • Strong attention to detail and ability to work in a fast-paced environment
  • Ability to collaborate effectively with cross-functional team members
  • Demonstrated ability to uphold the culture and values of the organization

Estimated Salary Range: $125,000 - $185,000 per year, based on location and industry standards.



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