Quality Engineer Principal Job in Framingham, Massachusetts US
Quality Engineer Principal
Description
Description
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com. Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Position Description
• Provide strategic input and support to the Corporate Quality Risk Management program including training materials, SOP development, facilitation and guidance to all Genzyme sites in accordance to the Risk Management standard.• Strategize and create new risk methodologies or customized risk tools for various quality system elements (e.g.: risk tools, risk reporting, QbD).
• Provide training to the organization on standardized risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools.
• Lead risk facilitation activities for various business applications, both internal and external to the CQO organization.
• Provide leadership and support over the Design Control and Technology Transfer processes within Biosurgery; including training, SOP improvements to meet compliance and customer preference objectives, project guidance.
• Participate as an independent reviewer on new product development teams (medium to high complexity) to ensure the Design Control process is being followed effectively.
• Interact collaboratively with cross-functional teams in a matrix organization. May lead and facilitate cross-functional teams, locally and globally, for highly visible projects.
• Identify and manage resources required to successfully execute projects.
• Communicate teams' progress to stakeholders, management and unit leaders.
Qualifications
-Bachelor's degree in Engineering or science discipline or equivalent.
-10+ years of quality/business process improvement experience in the medical device, biotech and/or pharmaceutical industry using various tools (FMEA, HACCP, process mapping, and root cause analysis tools).
-Project Management experience involving proven collaboration, initiation and execution skills leading to the successful completion of business improvements (med-large scale).
