Quality Engineer


Columbia, SC
Columbia, South Carolina


Last Day to Apply: May 15, 2014

Great People, Great Culture, Great Opportunity

Quality Engineer - Medical Devices

Columbia, South Carolina

 

We have been retained by our client, a successful privately held medical device manufacturer and distributor in Columbia, South Carolina, to attract exceptional candidates for consideration as their new Quality Engineer.

 

Their significant growth is creating this expansion position to oversee their Quality Management System. The position reports to the Quality Director and the successful candidate:

  • Will provide technical support for national Regulatory (domestic and international) Quality System compliance including literature searches, data analysis and charting to support Quality and Engineering metrics for the company’s Class 1 and Class 2 medical accessories and devices;
  • Will define and perform incoming inspection, both visual and destructive testing on raw and finished materials while handling documentation and recording;  
  • Will work with suppliers on quality issues, root cause and corrective actions on both parts and services;
  • Will assist in the maintenance and management of technical files;
  • Will assist Technicians, Outside Contractors, Suppliers, and OEM’s to complete technical tests required for corrective actions, improving completeness and accuracy of all work performed on behalf of the company; 
  • Will suggest or implement continuous improvement in the overall company system; 
  • Will perform internal and external audits; 
  • Will maintain and document company equipment calibration process; 
  • Will implement and maintain product and service quality metrics, including trend charting and graphics. 

Critical Knowledge, Skills and Experience Required

  1. 5 Years (minimum) quality engineering experience in a government regulated or certified industry such as automotive assembly or parts manufacturing, consumer products, medical device manufacturing, and/or DoD supply contractor,
  2. Bachelor of Science degree in EE, ME, Biomedical or Bachelor of Science in ME or EE Technology,
  3. Previous experience in the medical industry would be a plus,  specifically working with CE, FDA and ISO regulations and requirements,
  4. Familiar with and use of ERP systems such as SAP, 
  5. Familiar with the use of basic mechanical laboratory equipment such as microscopes, micrometers, calipers,  pull testers, hardness testers  --  experience working in a failure analysis laboratory would be a plus
  6. Experience working in a manufacturing environment – understanding of any of the following would be a plus;  metallurgy,  basic tin and tin/lead electronic soldering process,  plastic injection molding,  rapid prototyping
  7. In depth experience dealing with customers and customer complaints. Sensitivity to handling difficult customers in difficult and technical situations
  8. In depth experience dealing with suppliers. Showing the appropriate level of assertiveness to obtain data and force corrective action completion
  9. Previous experience supporting the validation process for product design
  10. Understanding and experience interpreting as well as enforcing QS9000 requirements in whatever industry version (ie. 16949, 13485, MIL, FDA, etc.)
  11. Excellent verbal and written communication skills as well as strong interpersonal skills
  12. Experienced user of  Microsoft  Word,  Excel,  Outlook – Use of MS Power Point, MS Access would be a plus
  13. Demonstrated fanaticism with attention to detail

 

Location:  Willing to work and live in or near enough to commute daily to Columbia, SC

The right individual will join a company that rewards and recognizes individuals who have demonstrated high integrity, are self-directed, but also enjoy working as part of a high-performing team, in a great company culture.

Columbia, South Carolina is 1.5 hours from the best beaches in the South and 2 hours from the Blue Ridge Mountains.

 

This company is an EOE/M/F employer. 

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