Brian Edwards

Lead Quality Engineer working with Drug eluting stents, Sterilization, DOE, cGMP, Clean room design and procedures, Validations and Verifications

• Developed training protocols in alignment with company quality standards and ISO 9000 regulations.
• Performed quality inspections and drafted reports to detail non-conforming material issues.
• Utilized knowledge of ISO 9000 standards to develop action plan for company certification.
• Contributed to root cause analysis to determine core reason for failures and errors.

v Wrote/ revised and gave advice on quality documentation, Method validations and transfers, analytical investigations, Trackwise deviations/change controls, quality plan actions

· Review and approve methods, specifications, SOPs, and other GMP documents

v Provided training, support, advice and proactive assistance with respect to the Roche quality systems

v Participated in the Roche Specification Governance meetings and track completion of actions involving the Roche Global Quality Laboratory.

· Provide quality oversight for the qualification of third party contract laboratories. Ensure activities are performed in a compliant manner at all third party labs and provide QA support where needed ( deviations, change controls, validations, transfers.)

· Stayed current with all relevant Roche quality standards and in conjunction with management, ensure the Roche Global Quality Laboratory is compliant with those standards including Global Travel.

• Built strong rapport with team members, management and clients to facilitate efficiency and productivity.
• Demonstrated product and quality expertise in product inspections.

• Founded and managed Engineering business, growing revenue from to $3M in first year and to 20M
• Managed day-to-day business operations, including accounting, finance, HR, marketing and public relations.
• Established, optimized and enforced business policies to maintain consistency and high-quality standards across [Industry] operations.
• Established and administered annual budget with effective controls to prevent overages, minimize burn rate and support sustainability objectives.

v ISO, FDA & USDA Certified Chemical Coatings for the Food and Pharmaceutical Industrial Clean Room construction

v 12 yrs. Supplier Quality Management and Engineering