Quality Assurance Engineer

Fenwal is a global leader in medical technologies focused on improving blood safety and availability for patient care.  A $600+ million business, Fenwal is a growing company that develops leading products, services and technologies used to collect, process and store blood and its vital components.    Over 4000 people around the world work for Fenwal, helping each day to improve people’s lives while developing a rewarding career.

We currently have an opportunity for a Quality Assurance Engineer who will analyze, develop and implement processes, programs and systems to ensure product quality for Fenwal.

Responsibilities will include:

• Gather and analyze complaint and repair data to identify “root cause" of Quality problems.
• Develop, implement and monitor various reporting systems concerning product quality, internal PPM, External PPM, warranty cost and Cost of Non Quality.
• Work with CAT teams, Sustaining Engineering and manufacturing sites to development and implement corrective actions.
• Coordinate QA efforts on a specific product group to assure CAPAs are opened appropriately, are progressing at an acceptable pace, and are driven to corrective action (i.e. both process and product root cause determination).
• Assist in the management of ongoing activity associated with the CAPA systems and Post Market Surveillance.
• Gather and present data for CAPA Review Meetings, Program Review Meetings, etc.
• Interface with various parts of the organization to obtain and understand potential sources of Quality problems.
• Actively participate in New Product Development process.
• Drive the use of quality and reliability disciplines at the system level to support electrical and mechanical development and support teams.
• Implement FCAs and products Holds when appropriate for the assigned product line.
• Participate in requirements definition to ensure that reliability/quality, functional and safety targets are met.
• Perform risk assessment and analysis.

• BS degree in Engineering (Mechanical or Electrical preferred); CQE certification preferred
• 4-6 years experience with Product Development or Quality  and knowledge of Medical Device regulations (21 CFR 820) and Drug regulations (21 CFR 210 & 211)
• Working knowledge of lean manufacturing techniques and principles with 1-3 years practical experience
• Experience with design and testing of electromechanical systems
• Proficiency with Risk Management tools such as Hazard Analysis, FMEA and FTA in addition to Robust Engineering tools such as DOE, Parameter Design and Tolerance Design
• Familiarity with Design for Manufacturability and Design for Reliability a plus
• Strong leadership skills and ability to drive change
• Strong analytical and problem solving skills
• Excellent verbal and written communication skills 

Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing.

Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce.