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Founded in 1965, MRINetwork has grown into one of the largest and most successful recruitment organizations in the world. With a full range of Permanent Placement options ranging from Retained or Contingency Search to Contract Staffing and Large-scale Project Search solutions, MRINetwork gives you the flexibility you want at the pace you demand.


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Job Description 


An excellent Opportunity with a major Medical Device company with success delivering creative and innovative products. Always on the leading edge!  Offers a progressive, team-based work environment, where performance is rewarded. Excellent succession planning and organization development. An exceptional opportunity for a proven performer!  Great location, competitive salary and benefits!  Base pay:  $95,000 - $105,000, plus Bonus!


  • Will lead a department of well educated, trained, motivated and respected quality engineers to support new product development, product line extensions and acquisitions while providing them with the proper tools and guidance to be successful in a work environment conductive to personal and professional development for success.
  • Prepare and maintain department budgets.
  • Hire, train, develop, review and manage exempt and non-exempt employees.
  • Provide Quality Engineering support to assist in resolving quality issues that surface in the field.
  • Prepare and implement divisional policies relating to quality, project management, product/process development, design control regulations, etc.
  • Create, review and approve Quality System Documents.
  • Create, review and approve Product Documents for products purchased, manufactured and/or distributed by the company.
  • Create, review and approve Protocols, Process and Product Validations and Stability Protocols.
  • Create, Review and approve documents required for Design History File.
  • Create and Review Risk Assessments such as FMEA, FMECA or FTA.
  • Perform Internal of Supplier Quality System Audits.
  • Ensure compliance to Corporate, Division and Department procedures.
  • Keep up-to-date with tracking and trending of Quality Indicators.  Develop Quality indicators to enhance quality of products and business performance.
  • Serve as an Independent QA Reviewer and Chairperson for Design Reviews.
  • Participate in worldwide business travel as required.




 

Job Requirements 

  • Bachelor's Degree in Engineering, Science Technology or Business.  Master's Degree a plus!
  • 8+ years experience in a "decision-making" quality engineering position or equivalent quality related experience.
  • Must have at least 2 years experience in an FDA Regulated Industry (Medical Device, preferred) NO exceptions.
  • Must be an American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager.
  • Management experience with extensive knowledge of medical device regulation, industry or international standards.  Ability to understand Division and Plant Quality Systems and improve business efficiency.  Ability to interface with regulatory bodies to present technical information.
  • Experience in writing protocols/validations and fundamental knowledge of validation principles.
  • Understand basic applied statistics, statistical sampling plans and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
  • Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
  • Broad knowledge of manufacturing processes.
  • Excellent communication skills (verbal, written and presentation).  Understands how to present information dependent upon the level of the audience.
  • Understanding of Fundamentals of Engineering Principles.

MUST HAVE FDA REGULATED MEDICAL DEVICE EXPERIENCE!

TO BE CONSIDERED, PLEASE E-MAIL YOUR RESUME IN WORD DOC FORMAT TO:  [Click Here to Email Your Resumé]
 


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