Engineer - Medical Device - MED#224
Massachusetts
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Date Posted: |
03/04/09 |
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Date Available: |
03/02/09
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Descriptions: |
Executive Office Services is privileged to partner with a Medical Device Manufacturing and Production in the Massachusetts area that is seeking a Medical Device Engineer.
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Responsibilities: |
This position will provide technical support and take a leadership role in quality engineering functions in manufacturing and product development in compliance with FDA, ISO 13485, and internal procedures.
Direct quality activities in injection molding and extrusion device manufacturing such as inspection methods and Material Review Board (MRB).
Support product development such as design change and review, quality planning, risk evaluation, and validation.
Supervise Quality Assurance Inspectors if needed.
Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs.
Audit internal and vendor processes and procedures.
Participate in Continuous Improvement Projects (CIP) for both processes and business systems.
Develop training programs for inspection and engineering.
Represent company during customer or regulatory audits as needed.
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Qualifications: |
Although, Individual are encouraged to apply, however, the Ideal candidate with the following experience will only be considered:
Must have a B.S. (Technical Degree Preferred) Past work experience with a Medical Device Company or similar Minimum 7-8 years QA Engineering experience in a Medical Manufacturing Environment ASQ certification highly desired Medical Device/Extrusion experience preferred.
Regulatory cGMP, QSR and ISO knowledge base Statistical Skills (DOE, SPC, Reliability, Gage R&R) Experience with risk analysis methodologies Experience in the area of manufacturing operations
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Salary Range & Benefits: |
$100K
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Contact Information
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To Apply: |
Please send resumes in Word Document Format or Email a Word Attachment Only. No PDF Files
Please Send resumes email to:
Executive Office Services.
CAREERS@EXESERVICE.BIZ
Phone: (510) 830-9721
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