Site Quality Head
About The Position
Join our team as Quality Director and make a meaningful impact on health and safety. In this leadership role, you'll guide quality assurance strategy and develop a culture of excellence across our manufacturing sites. Working at the intersection of innovation and compliance, you'll lead quality initiatives that ensure our products meet the highest standards while enabling scientific discoveries. You'll oversee all QA activities, maintain regulatory compliance, and work collaboratively to improve business outcomes. This position offers the opportunity to build and implement quality systems that support our mission of enabling customers to make the world healthier, cleaner, and safer.
Requirements
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of strategic quality leadership experience in regulated medical device or pharmaceutical manufacturing
- Demonstrated expertise in FDA CFR 820, ISO 13485/9001, MDR, and risk management (ISO 14971)
- Strong experience managing CAPA systems and quality improvement initiatives
- Proficiency in quality tools including FMEA, SPC, and risk management methodologies
- Experience with problem-solving techniques such as PPI, 8D, DMAIC, and PPS
- Experience leading and developing large quality teams (8-10 direct reports, 100+ indirect)
- Experience working with external regulatory authorities and managing inspections
- Ability to build cross-functional partnerships and collaborate at all organizational levels
- Proficiency in strategic planning and execution of quality initiatives
- Success in transitioning organizations from quality control to quality assurance
- Excellent communication and presentation skills
- Change management and organizational development capabilities
- Ability to travel 25-30% of time
Nice To Haves
- Preferred Fields of Study: Engineering, Physical Sciences, Biology, Chemistry, or related scientific field
- ASQ Quality Manager Certification preferred
- ASQ Lead Auditor Certification preferred
- Experience with Lean or Six Sigma improvement systems preferred
- Electromechanical manufacturing experience preferred
Responsibilities
- Guide quality assurance strategy
- Develop a culture of excellence across our manufacturing sites
- Lead quality initiatives that ensure our products meet the highest standards
- Oversee all QA activities
- Maintain regulatory compliance
- Work collaboratively to improve business outcomes
- Build and implement quality systems
Benefits
- Reasonable accommodation for individuals with disabilities to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
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
Director
Number of Employees
5,001-10,000 employees
