Quality Excellence Director
2 weeks ago
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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