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Jim C

Administrative Services Manager - Near 02703

Occupation:

Quality Engineer

Location:

Norton, MA

Education Level:

Bachelor

Will Relocate:

YES

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Degreed professional with 10+ years medical device quality engineering and managerial experience focused in manufacturing and R&D environments. Excellent leadership & interpersonal skills combined with expertise in team building, internal and external auditing, problem solving (RCA), facilitation, training, consulting, supplier partnering & supplier quality. & ACCOMPLISHMENTS: * ASQ Certified Biomedical Auditor & Certified Quality Engineer * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * Design Assurance and Risk Management (ISO 14971) * Process Validation - IQ, OQ & PQ * GMP - Good Manufacturing Practices * CAPA and Complaint Processing * Directed over 12 companies to achieve ISO 9001 & ISO 13485 Certification * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * CFR 21, Part 803 Medical Device Adverse Event Reporting * CFR 21, Part 806 Field Action Decisions * FDA 483 Response Experience * Orthopedic Implant Medical Device Experience * Former 3rd party ISO 9001 Lead Assessor - LRQA-Lloyds Register QA * Developed & implemented internal audit programs * Extensive facilitation experience with cross functional groups ASQ Certified Biomedical Auditor & Certified Quality Engineer * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * Design Assurance and Risk Management (ISO 14971) * Process Validation - IQ, OQ & PQ * GMP - Good Manufacturing Practices * CAPA and Complaint Processing * Directed over 12 companies to achieve ISO 9001 & ISO 13485 Certification * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * CFR 21, Part 803 Medical Device Adverse Event Reporting * CFR 21, Part 806 Field Action Decisions * FDA 483 Response Experience * Orthopedic Implant Medical Device Experience * Former 3rd party ISO 9001 Lead Assessor - LRQA-Lloyds Register QA * Developed & implemented internal audit programs * Extensive facilitation experience with cross functional groups

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