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Precision Spine is a young and dynamic company with the goal of delivering significant advancements for the treatment of spinal conditions to physicians and patients globally.  The Company is seeking motivated individuals who possess an entrepreneurial spirit, unparalleled integrity and the desire to make a difference.  If you feel these characteristics apply to you, please feel free to contact us regarding the available openings below.


Send Resume & Salary Requirements to:  resumes@precisionspineinc.com or fax to 601-500-5785


QC Engineer - Process Validation

Department(s) QA
Reports to Quality Manager

The QA Engineer will provide a depth of knowledge in the areas of medical device quality systems (ISO and FDA) to personnel in all areas of the company for process validations.  This person will work closely with the Quality Manager to optimize the present quality system, to support process and manufacturing process validation and software validation activities.

Summary of essential job functions

  • On occasion act as the QA representative and interact with project team members and provide guidance to ensure compliance to quality procedures
  • Ensure that QA system procedures align with company goals
  • Ensure in-process inspection requirements are satisfied
  • Participate in process FMEA’s and Risk Analysis activities
  • Ensure that product conformance is met through product development and manufacturing to meet customer satisfaction
  • Write, review and approve engineering protocols and reports
  • Participate in activities to obtain ISO certifications

Minimum requirements

  • BS degree preferably in mechanical engineering
  • Three years minimal experience working within a ISO 9000 and preferable FDA 21 CFR Part 820 environment
  • Experience in working in a project team environment
  • An understanding of process and software validations that has direct impact on products

Abilities required

  • Strong verbal and written communication skills
  • Familiarization with Mini-Tab software a plus
  • Be able to conduct Gage R&Rs
  • Six Sigma experience preferred
  • Be able to interpret mechanical engineering design requirements, tolerances and methods of manufacturing to ensure reliability and confidence
  • Be able to conduct process validations (IQ/OQ/PQ)
  • Be able to write Control Plans a plus
  • Experience in FMEA and Risk Analysis
  • Competent in MS Word, Excel.

 


Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

 

 

 


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