Main Responsibilities:

• Work with engineering to track, diagnose and develop product reliability improvements. Liaise with field service, engineering and supply chain on quality related matters.
• Work with contract manufacturers and suppliers to improve product quality from.
• Work with Director to assure engineering design processes and manufacturing processes are conducted in compliance with quality plan and ensure validation and testing protocols are robust. Instill an emphasis on design and test for reliability within the development activities. Ensure FDA and other regulatory requirements are met.
• Develop, implement and maintain a Supplier Quality Management Program.
• Build models (using Excel, Access or other applicable software) to track and report system performance data from a variety of sources. Automate data reporting, where practical.
• Using statistical analysis, identify trends and patterns and establish standard metrics for on-going quality assurance review and publish reports and recommendations to management.
• Assure control and proper disposition of nonconforming products.
• Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
• Conduct Internal Quality System Audits and assure corrective action is performed.
• Maintain and suggest improvements to quality system policies and procedures. Assist in related employee education.

Key Qualifications:

• B.S. in Electrical Engineering or Mechanical Engineering strongly preferred. Equivalent work experience will be considered.
• 8 or more year experience in some combination of Engineering and Quality roles, with at least 3 years in Quality function.
• Certification(s) in quality and/or reliability engineering from the American Society of Quality strongly preferred.
• Experience with electro-mechanical equipment, which must include some medical devices and preferably also includes some industrial product experience.
• Experience and a good working knowledge of FDA GMP regulations as well as experience working with contract manufacturers preferred.
• Superior and proven cause/effect or fault analysis and troubleshooting and reliability engineering results.
• Experience with fluidics systems and liquid solution is a plus.
• Ability to compile and analyze data from various sources to identify trends
• Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action.
• Self-starter who works with a sense of urgency and acts as a team player working with other disciplines.
• Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.
• Level of proficiency with Microsoft Office suite (Word, Excel, Outlook, Powerpoint). High degree of Excel proficiency a plus.