Jeffrey Habitz
washington
Summary
Dynamic operational leader with extensive experience at ThermoFisher Scientific, excelling in strategic planning and regulatory compliance. Proven track record in enhancing quality management systems and driving process efficiency. Skilled in team development and M&A strategies, achieving zero violations during audits while managing multi-million dollar budgets.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Operational Management Consultant
EIS Consulting Services
(remote)
04.2024 - Current
- Executed contractual agreement for provision of business and quality management services.
- Assisted large container manufacturer with ISO and AIB compliance for certification preparation.
- Developed quality control programs for manufacturing and assembly of consumer electronic products.
- Established quality control procedures to ensure compliance with domestic and international regulations.
Global Director of Regulatory & QA
Zagg, mophie Inc.
Salt Lake City
01.2012 - 03.2024
- Established international quality assurance department for consumer electronics and telecommunications accessories.
- Managed approximately 20 engineers, managers, and technicians, including design and machining staff.
- Oversaw injection molding supply chain across US, China, Hong Kong, Philippines, and other APAC locations.
- Collaborated with executives from Apple, Verizon, Samsung, AT&T, and Best Buy to ensure compliance.
Vice President of Operations
Leica Biosystems, a Danaher Corporation
Richmond
01.2006 - 01.2012
- Oversaw manufacturing of Class I and II medical devices for a large laboratory supply corporation.
- Managed operations across three manufacturing sites, supervising over 300 employees.
- Administered annual operational expenditures of $100M USD and $5M capital investments.
- Contributed to M&A activities, facilitating merger with Leica Biosystems and relocation of two facilities.
Vice President of QA/RA
ThermoFisher Scientific
Kalamazoo
01.1996 - 01.2006
- Ensured product quality and regulatory compliance across multiple Class I and II medical device manufacturing sites.
- Chaired Corporate Regulatory Compliance Committee to uphold industry standards.
- Conducted over 50 regulatory audits internationally, maintaining high compliance levels.
- Participated in federal and state regulatory inspections, resulting in zero violations.
- Obtained ISO 13485 certification to enhance operational credibility.
- Played a key role in M&A process, acquiring three medical device manufacturing facilities abroad.
- Managed quality control laboratory for anatomical pathology, ensuring accuracy and reliability.
- Led initiatives to improve compliance processes and quality assurance practices.
Education
Biomedical Science - Environmental Studies
Western Michigan University
Skills
- Strategic planning and execution
- Team development and leadership
- Process efficiency and lean methodologies
- Injection molding expertise
- Regulatory compliance (FDA, AIB, ISO)
- Sourcing from low-cost regions
- Corporate social responsibility
- Quality management system development
- Due diligence and M&A strategies
- Key performance indicators (KPIs)
- Budget development and management
Accomplishments
- Established APAC & Domestic Automotive and Electronics Injection Molding Supply Chain
- Developed ISO 13485 and ISO 9001 Certified Quality Management Systems
- Developed and Managed International Manufacturing and Quality Control Teams
- Realized >$130M USD by Relocating Four Medical Device Manufacturing Facilities
- Obtained FDA 510K Clearance for ~500 Class I and II Medical Devices
Affiliations
- Danaher Business System Talent Review Award
- Richmond City Award of Business Excellence
- Shenzhen China Best Practice nomination
- Apple Quality Supplier Award
Languages
Chinese (Mandarin)
Limited
Spanish
Limited
Certification
- Six Sigma
- Lean Manufacturing
- FDA Statistical Process Control
Websites
Volunteer
Legacy Assisted Living
Victim Impact Trainer
Stoney Creek Metro Park Clean-Days
References
References available upon request.
Timeline
Operational Management Consultant
EIS Consulting Services
04.2024 - Current
Global Director of Regulatory & QA
Zagg, mophie Inc.
01.2012 - 03.2024
Vice President of Operations
Leica Biosystems, a Danaher Corporation
01.2006 - 01.2012
Vice President of QA/RA
ThermoFisher Scientific
01.1996 - 01.2006
Biomedical Science - Environmental Studies
Western Michigan University
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