Strategic Quality Assurance Director
6 days ago
We are seeking a seasoned Senior Director of Quality to oversee our global quality assurance and regulatory compliance initiatives.
Key Responsibilities:- Develop and implement a comprehensive global quality assurance strategy, ensuring adherence to FDA, ISO 13485, and other relevant international regulations.
- Lead the development and execution of quality improvement initiatives, including root cause analysis and corrective action processes.
- Collaborate with cross-functional teams to integrate quality into product development and manufacturing.
- Establish effective communication with regulatory agencies and ensure timely reporting and resolution of compliance issues.
- Provide leadership and mentorship to quality assurance teams, fostering a culture of quality and accountability.
- Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum 10 years of experience in quality management within the medical device industry, with at least 5 years in a leadership role.
- Strong knowledge of FDA, ISO, and other global regulatory requirements for medical devices.
- Exceptional analytical and problem-solving skills, with a track record of driving quality improvements.
- Demonstrated ability to lead and motivate teams in a fast-paced, global environment.
$200k-225k per annum + bonus + benefits package.
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