Quality Engineer I

About the Role

Columbia Tech provides Time to Market Services at WARP SPEED™, including product development, manufacturing, global fulfillment, and aftermarket services. Clients include innovation leaders in the life-science, bio-discovery, alternative energy, semiconductor, power management, LED, medical, data storage, homeland security, and robotics and automation industries.

Responsibilities

• Lead by example and promote the criticality of strict compliance adherence at Columbia Tech.
• Assist in the training of personnel, including customers and suppliers, on workmanship and quality standards.
• Assure all outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introduction processes.
• Develop and execute Control Plans.
• Review device history records for quality approval as needed.
• Oversee 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.).
• Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.
• Meet or exceed established ECO implementation performance metrics.
• 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 non-conforming material issues resolution with suppliers.
• Lead the Quality Control inspection process.
• Develop skills as a Trainer to new QC Inspection resources.
• Develop quality and inspection plans.
• Assist in developing and executing supplier audit plans.
• Contribute to the ongoing assessment of current and new potential suppliers.
• Support continuous supplier improvement through collection of data and performing statistical analysis.
• Build strong rapport with customers and suppliers through data collection and metrics generation.
• 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 PM’s to develop optimal work order routings.
• Collaborate with Supply Chain, PM’s, and Operations on managing the Material Review Board (MRB) process.

Requirements

• 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.
• Strong electro-mechanical orientation.
• Minimum of 2 years professional experience in medical subassembly and finished device manufacturing. 3 to 5 years preferred. Significant and applicable professional experience may be considered in lieu of medical device requirements.
• Proven problem solver.
• Knowledge of IPC 610 and 620 standards beneficial.

Skills

• Advanced Level Skills in MS Word and Excel such as keyboard shortcuts, creating macros and forms, table techniques, working with images and text, pivot tables.
• Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross-functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.

Working Environment

Generally works in an office environment but may occasionally be required to perform job duties outside of the typical office setting.

Physical Requirements

• Interaction with people and technology while either standing or sitting.
• Must be able to communicate face-to-face and on the phone.