Join a leading global medical device manufacturing company committed to advancing health care through innovative products and solutions. We are seeking a highly experienced and strategic Senior Director of Quality to oversee our global quality assurance and regulatory compliance initiatives. The ideal candidate will have extensive experience in quality management within the medical device industry, with a strong focus on multisite oversight responsibilities. The position is in Massachusetts and the company is offering relocation assistance.
Key Responsibilities:
- Lead and manage the global quality assurance strategy, ensuring compliance with all regulatory standards, including FDA, ISO 13485, and other relevant international regulations.
- Oversee quality management systems across multiple manufacturing sites, ensuring consistency and alignment with corporate quality objectives.
- Develop and implement policies and procedures to ensure quality standards are met and continuously improved.
- Collaborate with cross-functional teams, including R&D, operations, and supply chain, to integrate quality into all aspects of product development and manufacturing.
- Drive the development and execution of quality improvement initiatives, including root cause analysis and corrective action processes.
- Establish and maintain effective communication with regulatory agencies and ensure timely reporting and resolution of any compliance issues.
- Provide leadership and mentorship to quality assurance teams across multiple sites, fostering a culture of quality and accountability.
- Monitor industry trends and emerging regulations to proactively address potential impacts on quality practices.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in quality management within the medical device industry, with at least 5 years in a leadership role.
- Proven experience in multisite oversight, managing quality operations across multiple manufacturing facilities.
- 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.
- Excellent communication and interpersonal skills, with the ability to influence at all levels of the organisation.
- Demonstrated ability to lead and motivate teams in a fast-paced, global environment.
Salary:
- $200k-225k + Bonus + Benefits
If you are interested, don't hesitate to apply!
