Facilitate compliance to applicable internal and external requirements during the product production cycle, manufacturing, and inspection of both of new and existing products. Collaborate with the R&D and Manufacturing portions of the organization to help facilitate the successful manufacture and inspection of robust products. Responsible and accountable for Quality Operations and Engineering deliverables required within the operations and inspection areas for the Irvine, CA site.

Training in Networking Skills and Job Hunting Strategies.

• Managed a team of 6-10 scientists and engineers working on multiple projects including manufacturing support, developing new instrument products and developing new reagents.• Re-engineered a series of protein reagents, eliminating a systemic problem and improving both performance and manufacturability of the products• Established customer-centered specifications based on valid statistical techniques. Won the Beckman Quality Award for saving millions of dollars in product re-manufacture and support costs.• Directed the integration of major analyzer and reagent products.• Supported manufacturing for the protein product line of liquid, lyophilized and dry-filled reagents.• Led a team of professionals from development, supply chain and quality to investigate issues, identify root cause, implement remedial action to eliminate problems and set controls in place to stabilize the process. Trained team in investigative process.

• Managed a team of 7 investigators that addressed and advocated customer complaints. • Established a sustainable and compliant CAPA system. • Managed CAPA projects that crossed department barriers.• Managed the customer complaint process.

• Managed a team of 5-20 scientists and contractors working on multiple projects.• Facilitated a cross functional team to define validation requirements for new products.• Developed validation strategies; focus on risk-based testing.• Led team that developed specifications for features; identified the key areas requiring validation.• Facilitated risk analyses and coordinate efforts to minimize or mitigate risks.• Led a team to design review and document the validation and verification tasks.• Held the functional groups accountable for quality and schedule of validation and verification tasks.• Led a team of developers and researchers of 7-15 individuals, Beckman and contract employees.• Developed and revised protocols to verify features, functions and system performance.• Won two Beckman awards for outstanding performance (one individual, one team).

• Provided system and chemistry support for the SYNCHRON product line.• Led chemistry product improvements and software validation efforts for the SYNCHRON CX3.• Represented Chemistry Development to project and customer complaint teams.• Led and assisted in reformulation efforts for CX3 reagents.• Helped create partnerships with groups outside Chemistry Development to improve system robustness

• Developed and validated an extensive line of reagents with a manufacturing partner.• Developed and validated applications for OEM reagents on KONE Progress Clinical Analyzer.• Evaluated new products and product improvements, validated when required.• Served as chemistry expert and systems consultant for KONE Progress customers.• Established and maintained service functions for KONE Microlyte electrolyte analyzer.• Managed quality and regulatory compliance and new product submissions (temporary assignment).• Developed protein separation methods for extractable nuclear antigens based on immuno-reactivity.• Developed, evaluated and validated automated immunoassays.• Evaluated and validated automated instrumentation as a third-party vendor.• Established and implemented protocols to certify instrument installations in customer laboratories.• Performed customer demos with sales organization, installed instruments in customer sites.

Developed chemistry reagents. Led transfer efforts from R&D to manufacturing.

Developed chemistry reagents. Support existing chemistry products. Perform research into ion selective electrodes; help develop transcutaneous oxygen biosensor