Quality Engineer I: Process & Compliance Champion

Columbia-Tech

Westborough (MA)

On-site

USD 70,000 - 85,000

Full time

3 days ago
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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 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.

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