Quality Engineer II

Job Title

We Design and Build Life-Changing Technology... and so could YOU.

At Coghlin Companies, we're a family-owned Time to Market Services™ organization helping innovative customers bring breakthrough products to life. Our subsidiaries, Columbia Tech and Cogmedix, deliver the expertise and speed that bring ideas to life.

Columbia Tech provides product development, manufacturing, global fulfillment, and aftermarket services, all with a Time to Market at WARP SPEED™ mindset - ensuring speed, quality, and flawless execution.

Cogmedix is an FDA-registered, ISO 13485–certified partner for medical device innovators, specializing in complex electromechanical, laser, and electro-optical systems. Our Medical Technology Brought to Life™ mission turns cutting-edge ideas into life-changing reality.

401(k), 401(k) matching, bonus based on performance, competitive salary, dental insurance, health insurance, opportunity for advancement, paid time off, profit sharing, training & development

Lead by example and promote the criticality of strict compliance adherence at Columbia Tech. Lead in the training of personnel on workmanship and quality standards, where applicable. As part of the Columbia Tech team, assure all outgoing product is manufactured in a compliant manner. Support process qualification/validation and new product introduction processes, where applicable. Development and execution of Quality Plans for customer accounts.

Review device history records for quality approval, where applicable. Support and execute Redline and Engineering Change Notifications (ECN's) processing. Collaborate with Project Managers (PM's) to analyze customer ECN's and ensure effective implementation to the production floor through proper use of the Engineering Change Order (ECO) process, including reviewing and communicating impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.),

as it pertains to Quality. Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality. Drive improvement of Columbia Tech Quality through analyzing non-conformances (NC's) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions. Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc.

Support Supplier Quality Engineering with non-conforming material issues resolution with suppliers, where applicable. Collaborate with cross-functional team to help determine root cause of customer issues. Support the Quality Control inspection process, where applicable. Develop specific Quality Assurance Forms (QAF's), when required. Provide Training, as needed. Support the development of quality Receiving Incoming Inspection (RII) plans, as needed. Assist in regulatory audit for customer accounts.

Continually build strong rapport with customers through data collection, metrics generation and presentations. Promptly respond to manufacturing floor quality issues, taking appropriate action within the Columbia Tech Quality System. Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions. Collaborate with Engineering to develop optimal work order routings, where applicable. Collaborate with Supply Chain, PM's and Operations on managing the Material Review Board (MRB) process.

Support improvement projects, where applicable.

Positive attitude, self-motivator, and tenacious follow up required. Superior customer service attitude. Excellent teamwork, communication, and interpersonal skills. Bachelor's degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements. Minimum of 5 years professional experience in electro-mechanical manufacturing field preferred. Experience in ISO 9001 requirements is…