Senior Operations Quality Engineer

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Senior Operations Quality Engineer

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    Senior Operations Quality Engineer
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The Senior Operations Quality Engineer, who works under the direction and supervision of the Quality Assurance Manager – Production, leads the planning and execution of projects and activities for the facility to improve product and process quality, and analyzes quality data (complaints, process non-conformances, process capability, etc.). The Senior Operations Quality Engineer will also be a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction.

This individual is responsible for supporting the company's Instrument Manufacturing Process within the Milford plant and for supporting the nonconforming product process within the manufacturing facility.  Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, leading Corrective Action and Preventive Action (CAPA) investigations, and driving improvement activities and projects related to product and process quality.  Additional responsibilities include completion of nonconforming products records within Trackwise, active member of Material Review Board (MRB), and maintain physical and transactional control of discrepant material.  This position is hands-on in a fast-paced environment which will interact with multiple functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.


  • Identify areas for improvement within the manufacturing and quality management system and drive improvement for each area identified.
  • Review and approve deviations for manufacturing.
  • Drive failure investigations to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
  • Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements or the quality management system / GMP.
  • Review and approval non-conformance investigation and dispositions.
  • Support change management activities to ensure process changes are managed and approved effectively
  • Perform weekly metrics reports to determine current health of nonconforming process, as needed.
  • Lead a minimum of two continuous improvement projects each year to improve the processes related to product conformity and management of nonconforming product.
  • Provide guidance and ensures compliance with ISO13485:2003, 21CFR820 and applicable good manufacturing practice regulations within the company


  • Qualified individual should have a Bachelors Degree in Engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineering, etc.), Business, Mathematics, Science, or technical field with emphasis on statistical skills. Advanced degree preferred.


  • Minimum 4 years of experience in Quality Assurance or related field within a regulated industry (ISO 9001, ISO 13485, AS9100, or TS16969)


  • Minimum 3 years of experience in process improvement and lean manufacturing
  • Superior leadership, facilitation, and communication skills.
  • Demonstrated implementation of continuous improvement methodologies.
  • Working knowledge of ISO Quality Management Systems.
  • Exposure to process and/or software validation methods
  • Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing – GD&T), along with electrical and fluidic schematics.
  • Excellent communication and interpersonal skills.


Desired Qualifications:

  • FDA 21CFR 820 / ISO13485:2003 / cGMP knowledge base
  • ASQ Certified Quality Engineer (CQE)
  • Experience in an electromechanically in the medical device manufacturing facility
  • Operational Excellence / Six Sigma / Lean training or certifications
  • Working knowledge of ISO quality management systems 13485 and 21 CFR part 820
  • Experience supporting the manufacture of complex electromechanical assemblies
  • Project Management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc.)
  • Experience using Sparta TrackWise
  • Experience using SAP or Oracle
  • Knowledge of various quality systems




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