Quality Engineer II

Benefits:

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401(k)

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401(k) matching

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Health insurance

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Opportunity for advancement

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Paid time off

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Profit sharing

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Dental insurance

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Job Summary Supports assigned customers to assure best-in-class quality for product and provide seamless communication between Columbia Tech project team and customer.

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Duties and Responsibilities

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Lead by example and promote the criticality of strict compliance adherence

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Lead in the training of personnel, including customers and suppliers on workmanship and quality standards.

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As part of the Columbia Tech team, assure all outgoing product is manufactured in a compliant manner.

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Support process qualification/validation and new product introduction processes.

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Development and execution of Control Plans.

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Review device history records for quality approval as needed.

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Oversee and execute Redline and Engineering Change Notifications (ECN’s) processing

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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.).

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Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.

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Meet or exceed established ECO implementation performance metrics.

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Drive improvement of Quality through analyzing non-conformances (NC’s) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions.

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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.

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Support non-conforming material issues resolution with suppliers.

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Collaborate with customer to help determine root cause of customer issues.

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Lead the Quality Control inspection process.

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Develop skills as a Trainer to new QC Inspection resources.

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Development of quality and inspection plans.

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Under direction of the Quality Manager, Assist in the development and execution of supplier audit plans.

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Contribute to the ongoing assessment of current and new potential suppliers.

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Support continuous supplier improvement through collection of data and performing statistical analysis.

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Build strong rapport with customers and supplies through generating data and presenting quality metrics to meet or exceed mutually defined expectations.

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Promptly respond to manufacturing floor quality issues, taking appropriate action within the Columbia Tech Quality System.

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Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions.

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Collaborate with PM’s to develop optimal work order routings.

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Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process.

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Other duties as assigned.

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Qualifications

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Positive attitude, self-motivator, and tenacious follow up required.

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Superior customer service attitude.

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Excellent teamwork, communication, and interpersonal skills.

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Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.

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Strong electro-mechanical orientation.

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Experience in ISO-13485 certified required and cGMP organizations preferred.

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5 years professional experience in medical subassembly and finished device manufacturing required. 6 to 10 years preferred.

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Certified Quality Engineer (CQE) preferred.

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Proven problem solver.

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Knowledge of IPC 610 and 620 standards required. Certified training beneficial.

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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.

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Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flowcharts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.

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Working Environment

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

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Physical Requirements

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Interaction with people and technology while either standing or sitting.

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Must be able to communicate face-to-face and on the phone.

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Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled__

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Columbia Tech is an Equal Opportunity Employer. Columbia Tech does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.