James Madden Email and Phone Number

• Quality Program Manager for strategic projects within organization.• Led quality activities associated with the shutdown of two facilities.• Developed quality plans and master validation plans for the transfer of production to multiple facilities within the organization.• Acting Quality Manager for facility during the shutdown process.• Won 2 Accellent Values awards for contributions to multiple projects.

• Quality Program Manager for the launch of a new production facility located in Penang, Malaysia.• Managed the development of an ISO 13485 compliant quality system for a startup of an international medical device component manufacturing facility. Certification was received 3 months ahead of schedule. Won Accellent Builder’s Award for contributions to project team. The Builder’s Award is presented in recognition of consistent, exemplary achievement, which enhances company performance.• Developed quality plan and master validation plan for a new greenfield factory.• Wrote and executed validation protocols (IQ, OQ, PQ and special process validation) for all equipment and processes within an 8 month period. (75+ pieces of equipment)

• Quality Project Manager for a new $2.5 Million revenue/yr production line in Juarez, Mexico facility. Won Accellent President’s Award for contribution to project team. The President’s Award is presented in recognition of unprecedented achievement in the areas of customer satisfaction, innovation, reliability and quality. • Site Quality Management Representative • Improved CAPA system performance by reducing oldest open CAPA from 206 days to 63 days. Reduced average days open for each CAPA from 93 days to 33 days. • Collaborated with engineering and operations to develop test methods and fixtures for incoming materials as well as finished goods.• Performed root cause investigation for customer complaints and process non-conformances. Improved root cause investigations resulted in a complaint reduction of 24% and an NCR reduction of 20%. • Worked closely with customers and suppliers to resolve quality related issues and concerns.• Developed and implemented a new non-conforming material report system that allows for easier trending of issues.

Managed multiple equipment suppliersConducted design reviews with supplier to ensure assembly process was acceptableDeveloped validation strategy for new production equipment

Provided outsourced Quality Engineering support to multiple customers. International travel to Ireland for support of customer needs.

Quality Engineer (contract) for 3 production lines during time of regulatory audits. Trained 2 quality technicians and replacement quality engineer during the contract.

Led Qualification and Validation of multiple production lines and processes. Validation activities included autoclaves, pouring machines, and automated filling and capping lines.

Provided Validation Engineering Consulting to Pharmaceutical Companies under FDA distress. Developed validation protocols (IQ, OQ, PQ) for multiple equipment types including sterilizers, incubators, VHP Isolators, radioactive isolators. Analysed results of validation activities and provided concise reports to the customer to use to complete FDA recovery plans. Developed interactive training module using picture based work instructions for multilingual employees.