CT - 5134 Quality Engineer II
About The Position
Columbia Tech is seeking a Quality Engineer II to lead by example and promote strict compliance adherence. This role involves training personnel on workmanship and quality standards, ensuring all outgoing product is manufactured in a compliant manner, and supporting process qualification/validation and new product introduction. The Quality Engineer II will develop and execute Quality Plans, review device history records, and support Engineering Change Notifications (ECN's) and Engineering Change Orders (ECOs). This position plays a key role in driving quality improvements by analyzing non-conformances, performing root cause analysis, and implementing corrective and preventive actions. Collaboration with internal groups and customers is essential for determining the root cause of issues, complaints, and CAPAs. The role also involves supporting supplier quality, quality control inspection processes, and assisting in regulatory audits. Building strong customer rapport through data collection and presentations, promptly responding to manufacturing floor quality issues, and collaborating with various teams to identify trends and implement corrective actions are also key responsibilities. Additionally, the Quality Engineer II will collaborate with Engineering on work order routings and with Supply Chain, PM's, and Operations on the Material Review Board (MRB) process, and support improvement projects.
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.
- Minimum of 5 years professional experience in electro-mechanical manufacturing field preferred.
- Experience in ISO 9001 requirements is preferred.
- Strong electro-mechanical orientation.
- Proven problem solver.
- Knowledge of IPC 610 and 620 standards beneficial.
- Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images, text and 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.
- Certified Quality Engineer (CQE) preferred.
Nice To Haves
- Knowledge of IPC 610 and 620 standards beneficial.
- Certified Quality Engineer (CQE) preferred.
Responsibilities
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
