Quality Assurance Specialist

4 weeks ago

Westborough, Massachusetts, United States Coghlin Companies Full time
Job Summary

Columbia Tech is a leading provider of Time to Market Services, offering product development, manufacturing, global fulfillment, and aftermarket services to innovation leaders in various industries. As a Quality Engineer I, you will play a critical role in ensuring best-in-class quality for our products and providing seamless communication between our project team and customers.

Key Responsibilities
  • Lead by example and promote strict compliance adherence at Columbia Tech.
  • Assist in training personnel, including customers and suppliers, on workmanship and quality standards.
  • Ensure all outgoing products are manufactured in a compliant manner.
  • Support process qualification/validation and new product introduction processes.
  • Develop and execute Control Plans.
  • Review device history records for quality approval as needed.
  • Oversee and execute Redline and Engineering Change Notifications (ECNs) processing.
  • Suggest improvements to ECN/ECO process that lead to improved efficiency, accuracy, and quality.
  • Meet or exceed established ECO implementation performance metrics.
  • Drive improvement of Columbia Tech Quality through analyzing non-conformances (NCs) and performing root cause analysis of discrepancies.
  • Collaborate with internal groups and customers to determine root cause of customer issues, Complaints, and CAPAs.
  • Support non-conforming material issues resolution with suppliers.
  • Collaborate with customers to determine root cause of customer issues.
  • Lead the Quality Control inspection process.
  • Develop skills as a Trainer to new QC Inspection resources.
  • Develop quality and inspection plans.
  • Assist in developing and executing supplier audit plans.
  • Contribute to the ongoing assessment of current and new potential suppliers.
  • Support continuous supplier improvement through data collection and statistical analysis.
  • Build strong rapport with customers and suppliers through data collection and metrics generation.
  • 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 corrective actions.
  • Collaborate with Project Managers to develop optimal work order routings.
  • Collaborate with Supply Chain, Project Managers, 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 science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
  • Strong electro-mechanical orientation.
  • Minimum of 2 years professional experience in medical subassembly and finished device manufacturing. 3 to 5 years preferred. Significant and applicable professional experience may be considered in lieu of medical device requirements.
  • Proven problem solver.
  • Knowledge of IPC 610 and 620 standards beneficial.
  • Advanced Level Skills in MS Word and Excel such as keyboard shortcuts, creating macros and forms, table techniques, working with images and text, 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.
Working Environment
  • 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.

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