Diane Kulisek

Simi Valley, California, United States

Yearly Stats: $0 Earned |

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Diane Kulisek

Quality Assurance Engineering, Management and CAPA Consulting

Quality Assurance Engineering, Management and CAPA Consulting services for, primarily, the Medical Device industry. Significant expertise in Aerospace and Consumer Products, as well.

Keywords: Quality Assurance Management System QMS Regulatory Affairs RA Compliance 510k Cross-functional Team Culture Change Design Specification Process Control CCB Risk Assessment Mitigation FMEA Process Verification Validation IQ-OQ-PQ Corrective Action Preventive Action CAPA Root Cause Analysis RCA Audit Quality Audit Internal Audit Supplier Survey Supplier Statistical Analysis Metrics CpK SPC Six Sigma Lean DMAIC Kaizen Inspection Material Review Board MRB Aerospace Medical Device Environmental Safety Consumer ISO 9001 ISO 13485 ISO 14971 AS9100 ISO 14001 ISO 26000 Standards FDA Q9 21 CFR 820 cGMP QSIT GMP cGMP GxP 510k Submission 483 Warning Letter Remediation Training Coaching Mentoring

Work Terms

$100/hour plus actual travel advanced or reimbursed, if required