Buffi Boucher

With 30+ years invested at Karl Storz my knowledge and experience had me working on a variety of special projects working remotely, highlights below:

• GDP - performed documentation audits to ensure GDP compliance
• Documentation updating - Old template to new template transferals.
• Forms - updating for proficiency and create sticker style for ease information transfer.
• Identify areas fro improvement in documentation
• Write change orders to support QA/MFG
• 2023-24 project to obsolete mfg materials that are no longer mfg using using

New product introduction (Video Endoscopes)- worked harmoniously with Development/Engineering/QA/QC and Mfg from prototype to production:

• Drafted technical documents/Create change orders to move them to MFG implementation.
• Prototype inspection and test
• Communication of test results and assisting with problem solving
• Handoff to mfg/quality insp. – providing training and continued support.

Perform process audits to ensure compliance -ISO 13485, ISO 9000/9001, FDA 21 CFR 820, etc. Familiar with ISO 14001.

Develop and Implement Preventive Maintenance programs. Install and maintain equipment.

Perform first piece inspections, routine receiving inspections, final test inspections etc as needed to ensure on time delivery to customers.

Maintain GDP, record maintenance and data entries using SAP/EXCEL/Word ot other data collection methods.

Sampled materials and products to conduct in-depth measurements and tests.

Helped uncover and fix production problems in order to reduce overall defect rates.

• Maintained comprehensive documentation of QA activities, supporting effective communication between departments and facilitating process improvements.
• Using Lean Mfg methodology to effectively Collaborate with cross-functional teams to drive continuous improvement initiatives throughout the organization.
• Oversaw onboarding and training of new employees to promote qualified and well-coordinated quality assurance team.
• Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance staff.
• Established and tracked quality department goals and objectives met the delivery to customer 1 day turn time.
• Addressed non-conformance issues, pausing production to correct errors.

• Micro Optics Inspection specialist as Mil standards changed to ISO 10110 standard. Worked collaboratively with QA/MFG/Vendors to learn and implement new standards.
• Sampled materials and products to conduct in-depth measurements and tests.
• Maintained compliance with industry standards by conducting regular audits and updating quality control procedures as needed.
• Conducted root cause analysis for recurring defects, enabling targeted corrective actions that reduced future occurrences significantly.
• Participated in Lean Manufacturing initiatives by identifying areas of waste, streamlining processes, and reducing overall production time without sacrificing quality standards.
• Adhered to safety and 6S to comply with agency and regulatory mandates.
• Made recommendations on ways to improve testing procedures, production processes and training.
• Liaised between quality control and other departments and contractors, providing project updates and consultation.