Quality compliance shouldn't bottleneck your floor.
Practical, BS-free Quality & Operations partnerships for small-to-midsize manufacturers and biotech companies in the Portland Metro area.
Our Services
•Quality Management Systems (QMS): Designing, implementing, and sustaining practical systems tailored to ISO 9001, ISO 13485, and FDA cGMP standards.•Technical Documentation: Fast, flat-rate creation of SOPs, work instructions, and batch records that your team can actually understand and follow.•Operations & Facility Support: Hands-on assistance with facility setup, facility closure, visual inventory management (Kanban), and manufacturing process improvement.•Auditing & Compliance: Internal auditing, gap assessments, CAPA management, and preparation for external ISO audits and FDA inspections.
Meet Your "Anti-Consultant"
I build systems that actually work together. With over 20 years of hands-on experience, I’m not a traditional consultant who hands you a 50-page binder of theoretical rules and walks away. I am a Lean Six Sigma Black Belt and a pragmatic Operations Manager. Most companies treat Quality and Operations like opposing forces. My approach is different. I provide the daily, hands-on support you need to meet strict quality requirements without slowing you down.
Let's Get To Work
Serving the greater Portland Metro area on-site, and available globally for remote support. Reach out below, and I will get back to you within 24 hours.