Sr. Quality Engineer

About the role

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

Responsibilities

• Analyzes data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
• Manages multiple tasks and drives execution of change management plans
• Led or manages process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Six sigma, additional root cause analysis and project management techniques are routinely employed
• Writes test protocols, tests, collects data, and writes reports to validate against plan to ensure product is used as intended

Requirements

• Sound working knowledge and understanding of FDA 21 CFR 820 and ISO 9000:2015 and ISO 13485:2016
• Ability to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
• Ability to effectively manage multiple tasks and drive execution of change management plans
• Ability to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Six sigma, additional root cause analysis and project management techniques are routinely employed
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Experience with complaint investigation
• Professional certification preferred. Six Sigma, ASQ, AAMI
• Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
• Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
• BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience. Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Experience and understanding of electro-mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.