Quality Assurance Operations Manager
Resume:
Experience
North American Operations Manager
Leica Biosystems, Danaher Corp., 2006 – 2012
Directly responsible for the manufacture of Class I and II medical devices for a large laboratory supply corporation.
• Manage all levels of operational personnel at three manufacturing locations
(300+ employees).
• Responsible for $100M USD OPEX, $5M capital expenditure annually.
• Played a key role in M&A process (merged with Leica Biosystems and acquired/relocated two manufacturing facilities).
Jeffrey Habitz
Quality Manager
Zagg, mophie Inc., July 2013-March 2020
Developed an international quality assurance department for the manufacture, import and distribution of consumer electronics and telecomunication accessories.
• Managed ~20 quality engineers, managers and technicians to include percision machining and design staff for injection molding.
• Responsible for injection molding supply base in US, China, Hong Kong, Philippines and other APAC region locations.
• Worked closely with executive level representatives from Apple, Verizon, Samsung, AT&T, and Best Buy.
Biomedical Science
Environmental Studies
Western Michigan
University
Executive Strategic Planning
Team Development
Process Efficiency/Lean
Injection Molding
FDA, AIB, ISO Compliance
Low Cost Region Sourcing
Social Responsibility
QMS Development
Due Diligence / M&A
Key Performance Indicators
Budget Development
Operations & Quality Assurance Management
63139 East Charleston
Washington, MI 48095
***********@*******.***
Skills
Education
QA/RA Manager
ThermoFisher Scientific, 1996 – 2006
Directly responsible for product quality and regulatory compliance of several Class I and II medical device manufacturing locations.
• Played a key role in M&A process acquiring three medical device manufacturing facilities abroad.
• Chaired the Corporate Regulatory Compliance Committee.
• Conducted over 50 regulatory audits abroad.
• Participated in numerous federal/state regulatory inspections with no reported violations (FDA, BATF, EPA, OSHA and DOT).
• Obtained ISO 13485 certification.
• Managed anatomical pathology quality control laboratory. Science Based Studies
Rochester Adams High
School
Accomplishments
Established APAC &
Domestic Automotive and
Elecronics 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
Quality Management Consultant
EIS Consulting Services., March 2020-Present
Contractual agreement to provide business and quality management services.
• Assisted a large container manufacturer with ISO and AIB compliance in preparation for certification.
• Developed quality control programs for the manufacture and assembly of consumer electronic products.
• Created Quality Control Procedures to comply with domestic and international regulations.
Profile
Results-driven Operations & Quality Assurance Professional with 20+ years practical experience managing domestic and international manufacturing/quality assurance teams. Proven success deploying ISO, AIB, FDA, CE, UL and internationally certified quality management sysems. Developed pertinent continuous improvement objectives, and key performance indicators for executive review.
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