Quality Engineer I

Job Description

Job Description

Benefits :

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Profit sharing

Quality Engineer I

Duties and Responsibilities :

• Lead by example and promote the criticality of strict compliance adherence at Columbia Tech.
• Assist 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 (ECNs) processing. Collaborate with Project Managers (PMs) to analyze customer ECNs 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 (NCs) 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 (QAFs), 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, PMs and Operations on managing the Material Review Board (MRB) process.

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.