Boris Tkach Email & Phone Number

Amsterdam, Noord-Holland, NL

• Represent the quality function in the selection of new suppliers and development of existing suppliers.
• Interface with suppliers daily for all quality and supplier process issues.
• Develop and lead APQP process for supplier ramp up including special process validation activities (IQ, OQ and PQ)
• Lead supplier qualification audits to ISO 9001, ISO 13485 and GMP in Asia, Mexico, Europe and US.
• Lead communication with suppliers, Global Commodity Managers, and other internal teams on appropriate issues and improvements. Monitor and drive corrective action and continuous improvement activities that directly.
• Lead initiatives with early supplier involvement in new product development to prevent potential quality problems.

Redmond, WA, US

• Responsible for managing the supplier quality of assign suppliers, while systematically improving supplier quality, schedule, and cost. Represent the quality function in the selection of new suppliers and development.
• Interface with suppliers on a daily basis for all quality and supplier process issues.
• Complete PPAP and special process validation activities (IQ, OQ and PQ)
• Monitor and drive corrective action and continuous improvement activities that directly impacted suppliers’ performance. Facilitate supplier projects that reduce the risk of poor quality.
• Drive initiatives with early supplier involvement in new product development to prevent potential quality problems.
• Perform supplier audits to ISO 9001, ISO 13485 and GMP in Asia, Mexico, Europe and US. Verified suppliers’ compliance to statement of work and specification requirements. Issue reports and implement closed loop.

• Responsible for managing the supplier quality of assign suppliers, while systematically improving supplier quality, schedule, and cost. Represent the quality function in the selection of new suppliers and development.
• Interface with suppliers on a daily basis for all quality and supplier process issues.
• Monitor and drive corrective action and continuous improvement activities that directly impacted suppliers’ performance. Facilitate supplier projects that reduce the risk of poor quality.
• Drive initiatives with early supplier involvement in new product development to prevent potential quality problems.
• Perform supplier audits to ISO 9001, ISO 13485 and GMP in Asia, Mexico, Europe and US. Verified suppliers’ compliance to statement of work and specification requirements. Issue reports and implement closed loop.
• Evaluate, develop and qualify potential suppliers in Asia, Mexico and Europe.

• Conducted supplier audits per engineering specifications, and D1-9000 Rev "A" standard
• Evaluated, developed and qualified potential suppliers in US, Asia and Europe
• Monitored supplier performance regarding quality
• Improved quality performance via quality plan implementation for assigned suppliers

• Planned quality management related to new/existing product development
• Performed quality-engineering reviews of design documentation for compliance with stated requirements.
• Implemented process metrics and continuous improvement program.
• Conducted dispositions of nonconforming materials and implemented appropriate corrective actions
• Planed and conducted supplier evaluations and assessments to support the cross-functional supplier selection team
• Performed supplier audits to ISO 9000 standards