Director of Quality Assurance
About the Role:
This is a unique opportunity to lead our quality operations team and drive excellence in all aspects of our business.
Job Description:
* Oversee critical projects for new product introduction, ensuring seamless execution and high-quality results.
* Provide strategic leadership to the Quality Engineering team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting.
* Manage validation studies and work closely with various internal and external stakeholders to ensure alignment with regulatory requirements.
Key Responsibilities:
* Quality Leadership: Be a key member of our quality leadership team and ensure our quality systems align with ISO standards and regulatory requirements.
* Team Management: Lead, inspire, and develop the Quality Engineering Team, promoting a culture of continuous improvement and innovation.
* Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies, resulting in increased efficiency and productivity.
* System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
* Quality Control: Oversee the activities of the Quality Control group, ensuring seamless integration and high-performance results.
* Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
* Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met.
* Regulatory Excellence: Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
* GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
Requirements:
* A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is highly desirable.
* 5+ years of experience in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
* At least 3 years of supervisory experience with a proven track record of team development.
* Experience preparing technical documentation and managing CAPA systems.
* Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a plus).
* Knowledge of FDA requirements and experience managing FDA audits.
* Experience with process validation, sterilization, and clean room environments is advantageous.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply:
If you are a motivated and experienced professional looking to take your career to the next level, please submit your application.
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