Craig Brockhaus
Engineer and Manager of Programs, Projects and Operations versed in QMS adherence within cGMP environments
- Role
- Senior System Engineer at Stryker Advanced Guidance Technologies
- Location
- Pompano Beach, FL, US
- LinkedIn followers
- 500 followers
About Craig Brockhaus
Senior Quality Engineer and Leader of Project, Program and Operations Management efforts within regulated environments adhering to cGMP.I work as an Engineer and as a Program & Project Manager to address areas scoped within ISO-13485, ISO-14971, ICH8/ICH9/ICH10, and USP aligning with FDA 21 CFR Part 820, Australia’s TGA and EU MDR et al. I combine my technical skill sets with practical insight to plan, manage and execute projects both as a PM and/or Engineering resource, in support of R&D, and QA/RA for compliance. Experience includes roles in R&D (Innovation & Technical Readiness), Systems, V&V, Technical/Manufacturing/Sourcing Transfers, CAPA Managment, Equipment Qualification and Process Validation (URS,DQ,IQ,OQ,PQ,PPQ,CSV,Cleaning,TMV), Post Market Surveillance (Clinical Planning and Followup), Operations and Risk Management.
Experience
Senior System Engineer
Stryker Advanced Guidance Technologies
Mar 2024 — Present · Miami-Fort Lauderdale, FL, US
Digital Robotics Enabling Technology
Education
Lansing Community College
Candidate Associates, Biology/Biological Sciences, General
2005 — 2012
Lansing Community College
Candidate Associates, Pre-Medicine/Pre-Medical Studies
2006
Ferris State University
Optometry
Michigan State University
Bachelor of Science, Packaging
1978 — 1983
Ferris State University
Candidate, Doctor of Optometry
2007 — 2009
Skills
- Inventory Management
- Pricing
- Transportation
- Business Management
- Quality Management
- Logistics Engineering
- Contract Negotiation
- Project Management
- Business Process Improvement
- Fda
- Project Planning
- Business Strategy
- Research
- Time Studies
- Medical Devices
- Team Leadership
- Industrial Engineering
- Capacity Planning
- Supplier Management
- Sales Operations
- Optical Metrology
- Team Building
- Capex
- Budgeting
- Process Engineering
- Contract Negotiations
- Safety
- Life Sciences
- Organizational Development
- Manufacturing Engineering
- Business Planning
- Operations Management
- Continuous Improvement
- Supply Chain Management
- Osha
- Demand Planning
- Purchasing
- Process Improvement
- Global Sourcing
- Change Management
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.