CT - 5237 Quality Engineer I

Columbia-Tech; Westborough (MA); On-site; USD 70,000 - 85,000; Full time

Job summary

Columbia Tech in Westborough, MA is seeking a Quality Engineer to lead compliance and drive quality improvements across manufacturing. You will train personnel, ensure product conformity, and support ECN/ECO processes with cross-functional teams.

Responsibilities include developing Quality Plans, reviewing device history records, supporting CAPAs, and collaborating with suppliers and customers to resolve quality issues.

Qualifications

• 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 engineering or science discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Minimum of 2 years professional experience in electro-mechanical manufacturing field preferred.
• Experience in ISO 9001 requirements is preferred.
• Strong electro-mechanical orientation.
• 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.
• Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting.

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 (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.

Job description

Columbia Tech
27 Otis Street
Westborough, MA 01581, USA

Description

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 (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 Manufacturing Engineers to develop optimal work order routings, where applicable.
• Collaborate with Supply Chain, PM's and Operations on managing the Material Review Board (MRB) process.

Qualifications

• 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 engineering or science discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Minimum of 2 years professional experience in electro-mechanical manufacturing field preferred.
• Experience in ISO 9001 requirements is preferred.
• Strong electro-mechanical orientation.
• 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.
• 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.

Salary Range: 70k-$85k annually, commensurate with experience

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.

Qualifications

Education

Preferred

Bachelors or better in Engineering or related field.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.