Senior Quality Engineer

This is a Fulltime, Permanent (Direct Hire) opening with a Medical Device OEM in the Research Triangle Park - NC area.

Senior Quality Engineer

• Assure that quality processes are compliant to FDA, ISO 13485 and “My client" requirements and procedures.
• Chair Material Review Board (MRB) for Class I and Class II medical devices.
• Manage product in the nonconforming product quarantine area ensuring proper identification and segregation and timely processing. Assist with nonconformance reporting.
• Act as liaison to suppliers with Supplier Quality Engineering, Engineering and Supplier Management.
• Provide supplier, inspection technique, quality system and processing knowledge for project teams.
• Support supplier interaction, including problem analysis, control plan development, process optimization, and other technical liaison requirements as necessary.
• Travel to suppliers to harmonize inspection methods and resolve issues.
• Supervise inspectors, technicians, contract resources, etc. as required or directed by Quality Manager.
• Plan and coordinate activities of inspection Associates for sterile and non-sterile devices based on business needs.
• Provide review of engineering drawings.
• Develop and implement First Article inspection processes.
• Prioritize and implement functional and/or dimensional testing of prototype components/devices for New Product Development.
• Train inspection Associates in interpreting specifications, inspection techniques/procedures and equipment operation.
• Develop recommendations to improve work methods, product quality and overall efficiency of teams.
• Apply the CAPA process for supplier and internal process issues.
• Provide guidance to all functional areas in utilizing the CAPA process to resolve problems.
• Provide monthly report of activities to direct supervisor (inspection statistics, overtime, test requests, etc.).
• Approve time records of inspection Associates and contractors.

Qualification Requirements:
10 years of solid medical device experience
3-5 years of supervisory or management experience
A Bachelors degree in Engineering

No sponsorship visa (H1-B, etc) candidates at this time, sorry.

Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:

COYOTE TECHNICAL & EXECUTIVE SOURCING

Phil Montoya

Director of Sourcing

80 SW 8th Street, Suite 2074

Miami, FL 33130

P: 305-423-7033

F: 305-423-7133

[Click Here to Email Your Resumé]

http://www.coyotesourcing.com/

For more job openings, please visit http://www.coyotesourcing.com/board.html