CT - 5135 Quality Engineer II - PCBA

Posted 4 Days Ago
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Westborough, MA, USA
In-Office
85K-110K Annually
Senior level
Other
The Role
The Quality Engineer II at Columbia Tech leads compliance and quality standards, supports process qualification, reviews device history records, and collaborates on Q&A activities. Responsibilities include analyzing non-conformances, managing quality inspections, and improving quality systems.
Summary Generated by Built In
 Duties and Responsibilities
  • Lead by example and promote the criticality of strict compliance adherence at Columbia Tech.
  • Lead in the training of personnel on workmanship (IPC-610) and quality standards, where applicable.
  • As part of the Columbia Tech team, assure all outgoing products are 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, when required.
  • 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 on 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) or update Quality information within the Process Control System (i.e. Aegis), when required. Provide Training, as needed.
  • Support the development of quality Receiving Incoming Inspection (RII) plans, as needed.
  • Development of quality and inspection plans.
  • 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 Columbia Tech’s Quality System.
  • Work with PCBA 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.
  Qualifications
  • Positive attitude, self-motivator and tenacious follow up required.
  • Superior customer service attitude.
  • Current or previous IPC-A-610 and/or J-STD-001 certification is preferred. Instructor level is beneficial.
  • 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.
  • Placement and inspection equipment knowledge, AOI, Mydata and Juki/Fuji preferred.
  • Minimum of 5 years professional experience in PCB quality manufacturing. 5 to 7 years preferred.
  • Proven problem solver.
  • Knowledge of IPC 620 standard beneficial.
  • Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images and text, pivot tables.
  • 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.
 Working Environment
  • Approximately 70% of the work is performed in a precision, PCBA production area. The remaining time will be spent in office and warehouse areas.
Physical Requirements
  • Interaction with people and technology while either standing or sitting.
  • Must be able to communicate face-to-face and on the phone.
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

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 needed.
Salary Range: $85k-$110 (commensurate with experience)
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.

Skills Required

  • Bachelor's degree, preferably in a science or engineering discipline
  • Minimum of 5 years professional experience in PCB quality manufacturing
  • Current or previous IPC-A-610 and/or J-STD-001 certification
  • Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques
  • Skills in MS Visio such as creating Visio diagrams, custom styles and templates
  • Certified Quality Engineer (CQE)
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The Company
HQ: Worcester, MA
504 Employees
Year Founded: 1885

What We Do

Coghlin Companies provides world-class Time to Market Services™ (TTMS) with a specific focus on the successful commercialization of industrial capital equipment and FDA-compliant medical devices through our wholly-owned subsidiaries, Columbia Tech and Cogmedix. Our TTMS model includes engineering, product development, manufacturing, global fulfillment, and aftermarket services. Coghlin Companies provides these services to a diversified group of equipment innovators in the medical, life sciences, robotics, industrial automation, 3D printing, advanced energy, security, military, semiconductor, LED, and pharmaceutical industries.

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