Senior Quality Engineer

Rhode Island | Quality Assurance / Safety

Senior Quality Engineer

Our client is a successful Contract Manufacturing concern that supplies the Medical Device space with unique products and services, taking advantage of their exceptional background in material science.  This location is experiencing continued double-digit growth and they are looking for hands-on, ISO 13485 skilled Quality Engineering talent. 

What’s the upside?  Where’s the opportunity?  Contrary to the large corporate environment, this position will NOT pigeonhole you.  You’ll be involved in the breadth of the QS including training, supply chain, root cause, document control, and auditing to name a few.  You will be expected to contribute to the ongoing development of the QS and well as look for opportunities for improvement.  You’ll work independently with little supervision, and be part of critically important development teams.  This is the kind of position that gives you the chance to show how Quality contributes to the top and bottom line of the business. 

Responsibilities:

  • Works on the floor with manufacturing as required to resolve Quality issues pursuant to deficiencies indicated by electronically collected data or customer complaint
  • Reviews and tracks data from the Supply Chain to ensure compliance to drawing requirements and regulations
  • Works closely with the QS Manager on auditing and training requirements
  • Plays a key role in internal/external auditing including maintenance of results, performance of audits and may implement remedial training as required
  • Active responsibility for Corrective and Preventative Action, identification of Root Cause, ensuring CAPA’s are closed per the QS, and review/results of Supplier responses are correct
  • Administers the company’s compliance DB
  • Interacts with external auditors including client and/or government agencies
  • Will be customer facing for Quality Planning and resolution of Customer Complaint
  • May be responsible for collection and analysis of data for presentation to management (i.e. MRB)

Requirements: 

  1. Bachelor’s Degree in an Engineering discipline, Science or other appropriate Technical skill; MS preferred
  2. 3 years’ hands-on experience in Med Device manufacturing or +5 years in general ISO/AS/TS regulated manufacturing
  3. Demonstrable examples of a highly developed problem-solving skill set; ability to identify appropriate data points, collection and analysis of the data for logical conclusion
  4. Strong background in the reading of drawings and interpretation of GD&T
  5. Excellent understanding of SPC and the use of Minitab
  6. Client-facing interaction requires excellent communications skills in both spoken and written forms
  7. Experience with the Microsoft Office Suite and Minitab required; experience with Compliant PRO and/or CAD, e.g. SolidWorks a plus
  8. Demonstrable knowledge of the IQ/OQ/PQ, and V&V processes
  9. ISO 13485/FDA QSR knowledge including CAPA, continuous improvement and Lean/Six Sigma
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