Medical Device Project Manager

Company Name: S & B Consulting Group
Location: Dallas, TX United States
Job Category: Healthcare
Job Type: Full Time- Direct Hire
Salary: United States dollar (USD)

Jennifer Simpson-Black
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Required Skills & Job Description

Must Have Skills: • Previous quality control experience. • Interpretation of engineering drawings, product specifications, procedures. • Use of metrology equipment.
Education: Bachelor's Degree

Description:

Client develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in Client employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.

Summary: Perform raw material, in process and final inspection activities. Continually review the quality system and procedures for adequacy and accuracy. Enforce FDA Quality System Regulations and ISO 9001. Identify and control non conforming material.

Major, On-Going Responsibilities:
- Audit manufacturing operations to assure compliance with written procedures.
- Use recognized sampling plans to determine statistical size of samples.
- Perform and document visual, dimensional and functional inspections of raw material, in process sub assemblies, finished product and returned material. Review and document all sterility testing and device history records for final release.
- Perform tests according to various protocol requirements.
- Develop and document standard operating procedures, inspection and test procedures.
- Prepare samples for biological testing.

Experience & Training:
- Previous quality control experience.
- Interpretation of engineering drawings, product specifications, procedures.
- Use of metrology equipment.
- Knowledge of FDA Quality Systems Regulation and ISO 9000 desired.
- Proficiency with data entry and basic computer skills
- Ability to generate graphs and reports using Excel is a plus
- Individual must possess good written and oral communication skills. Knowledge of Statistical Process Control (SPC) is beneficial.

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Contact Information Company Name: S & B Consulting Group Contact Name: Jennifer Simpson Black Contact Number: Company Website: http://www.sbconsultinggroup.net Additional Benefits: Company Description: Date Posted: 2010-04-01 16:09:33