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Quality Engineer - Med Device

Warsaw, IN 46582

Employment Type: Contract To Permanent Industry: Industry Job Number: 7812

Quality Engineer

Are you a Quality Engineer that has Med Device experience?  If you have experience with quality systems and are open to a long term contract position in Warsaw, this position is for you!  (This position will start out as contract and have the potential to become permanent in 2019.)

The Quality Engineer will be responsible for supporting cross functional needs related to New Product Development of medical device in a global regulatory environment, which will include:

Implementation, review and maintenance of procedures, work instructions and forms which ensure effective support of internal customers and assisting in the implementation of programs associated with product development/manufacturing transfer through all design and development life cycle phases.

The Quality Engineer will also serve as the liaison to Quality Assurance, Manufacturing, Product development and Regulatory Affairs on all topics of Quality.

What will you be doing?
  • You will support internal customers including but not limited to Manufacturing, R&D, Process Engineering and others as necessary and in accordance with applicable procedures and regulations.
  • You will represent Quality Engineering through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
  • You will develop and/or approve V&V protocols, technical investigations, engineering reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements.
  • You will attend regular communication meetings with cross-functional teams for the company and their suppliers to identify the root cause of problem and create remedial plans for short-term and long-term resolutions.
  • You will initiate/lead improvement projects on procedures and processes using Six Sigma and Lean Techniques.
  • You will conduct supplier audits and assist with new supplier qualifications
  • You will support the investigation and documentation of customer complaints
  • You will approve item set-ups in JDE
  • You will perform supplier-item linkages in JDE
  • You will review/approve First Article Packets

What you need for this position?
  • 3+ years medical device experience in a quality discipline preferred.
  • Bachelor degree in engineering or related field; preferably in mechanical or biomedical.
  • Must be able to read and interpret engineering drawings
  • Mastery of functional gaging and application techniques
  • Mastery of Geometric Dimensioning and Tolerancing (GD&T)
  • Working knowledge of statistical sampling techniques
  • Knowledge of quality systems, 21CFR820, ISO 13485 and applicable medical device regulations
  • Proficiency in risk analysis techniques, Six Sigma, and internal/external audits
  • Computer skills required including Microsoft Outlook, Excel, Word, Project, SharePoint, and Minitab

What’ s in it for you?
  • Competitive pay
  • Weekly pay
  • Direct deposit
  • Holiday and vacation pay after certain requirements are met.
  • Employer paid, ACA compliant, insurance plan which offers minimal essential coverage
  • Optional supplemental insurance

Send resumes to Gwen Kilgore – gkilgore@careertransllc.com

Gwen Kilgore

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