Quality Engineer II

About the role

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Responsibilities

• Develop, modify, apply and maintain quality standards and protocol for processing materials into finished products
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place
• Devise and implement methods and procedures for inspecting, testing and evaluating precision and accuracy of products and production equipment
• Design or specify inspection and testing mechanisms and equipment
• Conduct quality assurance tests and perform statistical analysis to assess cost of and determine responsibility for products or materials that do not meet standards
• Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
• Deliver and manage projects from design to implementation, adhering to policies
• May act as a mentor to colleagues or direct the work of lower level professionals

Qualifications

• University Degree (advanced education typically required)
• Minimum of 2 years of relevant experience
• Practical knowledge and demonstrated competence within job area obtained through advanced education combined with experience

Skills

• Design controls and risk management (FMEA)
• Requirements traceability within a regulated environment
• Quality Management Systems (QMS) concepts including CAPA, change management, and document control
• Ability to create and maintain clear technical documentation
• Data analysis and investigation of nonconformances
• Root cause analysis tools (Pareto, fishbone, basic SPC)

Location: North Haven, CT (on-site required)