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Skills

  • ISO
  • Management
  • Quality Assurance
  • Sops
  • Coaching
  • Complaint Management
  • Compliance
  • Leadership
  • Qa
  • Qms
  • Risk Management
  • Change Management
  • Compliance Consulting
  • Corrective Actions
  • Cost Reduction

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Services

  • QA Coaching for Start Ups

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    If you are still developing your first product or service but know that your investors and clients expect an effective, risk-based, quality management effort, weekly coaching services can begin with a...

    CoachingComplaint ManagementISOManagementManual

  • QA Support for Growing Companies

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    I your company growing? Having a few QA-related "growing pains"? Have you begun production but not yet commercialized your product? Have you developed marketing materials but not yet begun product...

    Complaint ManagementCorrective ActionsISOQaQuality Assurance

  • Gap Assessment for QMS Compliance

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    Acquisition or funding in progress? Divesting? Due diligence for regulatory compliance needed? Need to convey your quality compliance status? Quality Management System (QMS) gap assessment to a regulation...

    ComplianceCompliance ConsultingExecutive SummaryGap AssessmentInternal Auditing

  • Quality Metrics and Reporting

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    Production and Process Controls, Risk Management, Corrective and Preventive Actions, Verification and Validation. Post Market Surveillance. Management Responsibility. These are all top ranked areas...

    KpisQmsRisk ManagementTrend Analysis

  • Corrective and Preventive Action (CAPA)

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    Every organization has a moment when things don't go as planned. If you have found yourself facing a quality-related challenge I can hit the ground running and provide your organization with the critical...

    ComplianceQuality AssuranceRecordingRemediationRisk Management

  • Time to Raise the Quality Bar?

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    The only thing that never changes is the fact that things change. In today's fast-paced competitive business environment, being able to attract, develop and retain the best talent, increase revenue generated...

    Change ManagementCost ReductionEngineeringLeadershipLean

About

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

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