CT - 5216 Quality Engineer II

Columbia-Tech; Westborough (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Columbia Tech is seeking a quality-focused professional to lead compliance and quality assurance across electro-mechanical manufacturing. You will train teams, support process qualification, and drive continuous improvement using tools like PFMEA and Ishikawa diagrams.

You will collaborate with engineering and production to resolve NCs and implement CAPAs, ensuring supplier and internal quality meets customer expectations. A CQE is preferred.

Qualifications

• Bachelor’s degree in a science or engineering field; significant experience may substitute.
• Minimum 5 years in electro-mechanical manufacturing preferred.
• Experience with ISO 9001 requirements is preferred.
• Knowledge of IPC 610/620 beneficial.
• CQE certification is a plus.

Responsibilities

• Lead and promote strict compliance adherence at Columbia Tech.
• Train personnel on workmanship and quality standards.
• Ensure all outgoing product is manufactured in a compliant manner.
• Support process qualification, validation and new product introduction.

Skills

Quality Assurance

Electro-mechanical manufacturing

Root Cause Analysis

ISO 9001 knowledge

MS Excel advanced

MS Word advanced

Education

Bachelor's degree in engineering or science

Tools

MS Visio

Visio diagrams

FMEA tools

Job description

Columbia Tech
27 Otis Street
Westborough, MA 01581, USA

Description

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.
• 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 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.

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 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.
• 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.

Salary Range: $85k-$110k 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.

Leader

Inspires teammates to follow them

Detail Oriented

Capable of carrying out a given task with all details necessary to get the task done well

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.