QA PROFESSIONAL Durham NC



This position reports to Manager, Device Quality. This individual will be responsible for monitoring the quality of supplied parts and finished devices involving the performance of inspections, preparing NCMR reports, and data maintenance for supplied parts and finished devices. This 

POSITION RESPONSIBILITIES 

Support the development and implementation of processes, procedures and documentation to achieve quality objectives. 
Ensures that the Quality Control Laboratory remains in good standing with all regulatory bodies (OSHA, local/regional authorities, etc) and conducts business in a safe and effective manner. 
Support Supplier Quality Program including NCMRs, auditing, and metrics for internal/external vendors, and external 3rd party assemblers. Provides Quality subject matter expertise to quality technicians and manufacturing associates. 
 Conducts device release and qualification testing, including in-process inspections and testing and final inspection and testing. Ensures all documentation is complete before product release and addresses any gaps through Device Deviation process. Ensures compliance with customer-driven or regionally driven standards such as CE, ISO, etc. 
Supports continuous improvement initiatives & interaction with internal customers and suppliers. 
Adheres to standards and methods for inspection, testing, and evaluation, utilizing knowledge from cross-functional quality, engineering and biological areas. 
 Assists field service in the evaluation and resolution of device issues. 
 Assists with developing standardized work in the assembly process. 
 Responsible for the oversight of Quality Controls calibration program. 
 Maintains manufacturing work instructions to current procedures. 
 Initiate Engineering Change Requests for discrepancies found on Engineering specification associate is also responsible for oversight of the QC calibration program, and for the creation and maintenance of documentation. 


TECHNICAL SKILLS REQUIREMENTS 

 Experience with performing measurements using calipers, micrometers, thread gauges, and other hand tools 
Experience with CMM, Bore scope, and Optical measuring equipment desirable 
 Ability to interpret electrical schematics, mechanical drawings and knowledge of GD&T 
 Must be proficient in Microsoft Office applications; knowledge of Mini tab, Visio and MS Project is desirable 
 Experience with SAP software desired 
 Understanding of Lean and Six Sigma tools 
Excellent written and oral communication skills 


PHYSICAL POSITION REQUIREMENTS 

Will need to work in office, lab and assembly environment 
 Will need to be able to lift up to 25 lbs on a regular basis 
 May need to travel to visit supplier or hatchery, as needed (up to 10%) 


EDUCATION AND EXPERIENCE 

Bachelors degree in Science or Engineering with 2+ years of experience 
or 
High School Diploma with 5+ years of manufacturing/quality experience

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Reference number US_EN_99_025273_362670