Director of Q&RA MBD North America
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Job Location:
Lenexa, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our team as Quality Director and make a meaningful impact on health and this leadership role youll guide quality assurance strategy and develop a culture of excellence across our manufacturing sites. Working at the intersection of innovation and compliance youll lead quality initiatives that ensure our products meet the highest standards while enabling scientific discoveries. Youll 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 Bachelors Degree plus 8 years of strategic quality leadership experience in regulated medical device or pharmaceutical manufacturing
Preferred Fields of Study: Engineering Physical Sciences Biology Chemistry or related scientific field
ASQ Quality Manager Certification preferred
ASQ Lead Auditor Certification preferred
5 years proven experience as a site quality lead
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 (6-8 direct reports 50 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
Experience with Lean or Six Sigma improvement systems preferred
Excellent communication and presentation skills
Change management and organizational development capabilities
Ability to travel 25-30% of time
Electromechanical manufacturing experience preferred
Required Experience:
Director
Key Skills
- Crisis Management
- Marketing
- Public Relations
- Fundraising
- Media Relations
- Constant Contact
- Strategic Planning
- Social Media Management
- Team Management
- Public Speaking
- Wordpress
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
