Principal Quality Assurance Engineer
About The Position
Are you an experienced quality assurance professional ready to take your career to the next level? At Hologic we’re searching for a Principal Quality Assurance Engineer to lead strategic initiatives that optimize and enhance our Quality Management System. In this role, you’ll be responsible for ensuring compliance with global regulations, championing advanced quality tools, and driving continuous improvement across our divisional and global operations. If you’re passionate about mentoring leaders, solving complex challenges, and shaping the future of healthcare quality, we want to hear from you!
Requirements
- In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive.
- Expertise in compliance issues and regulatory expectations.
- Advanced knowledge of Quality Management Systems and risk-based approaches.
- Familiarity with global regulations and industry best practices.
- Awareness of digital quality tools, AI-driven analytics, and advanced quality monitoring solutions.
- Strategic thinking and ability to lead organization-wide initiatives.
- Strong data analysis and trend interpretation abilities.
- Excellent written, verbal, and presentation skills tailored for executive-level communication.
- Proficiency in implementing and controlling Quality Management Systems.
- Project management skills (certifications are a plus).
- Ability to mentor and develop senior QA employees.
- Independent decision-making and conflict resolution.
- Collaborative mindset to work cross-functionally with R&D, Regulatory, Marketing, and Quality teams.
- Proactive and adaptable to regulatory changes and business needs.
- Strong leadership and ability to inspire teams for continuous improvement.
- Detail-oriented with a focus on integrity and compliance.
- Minimum 12+ years in the medical device industry.
- Proven track record in quality system strategy, risk management, and regulatory compliance.
- Hands-on experience with mergers and acquisitions integration strategies.
- Demonstrated success in mentoring and developing QA leaders.
- Experience participating in third-party audits and regulatory inspections.
Nice To Haves
- Project management skills (certifications are a plus).
Benefits
- comprehensive training when you join as well as continued development and training throughout your career
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
