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A

CAPA Consultant

Apolis
🇺🇸 United States
Hybrid
3 months ago
$40 – $45 / hour
  • CAPA
  • Lean Six Sigma
3 months ago
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Not enough detail in this posting to match

  • Job Title: CAPA Consultant
  • Location: Cambridge MA
  • Tax Term (W2, C2C): Any
  • Job Type (Permanent/Contract) : Contract
  • Duration: 6+ months
  • Pay Range: $40 - $45/hr
Description:
  1. Your role:
  • Drive and/or own corrective and preventive actions.
  • Lead cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
  • Work cross-functionally with global stakeholders to ensure timely resolution of all CAPAs.
  • Report to senior management on status of CAPAs.
  • Be ambassador of the quality policy within the organization.
  • Monitor, identify, escalate and potentially lead Quality improvement efficiency initiatives in commercial operations
  • Participate in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
  • Take ownership of basic processes in the assigned area/areas to ensure that QMS is efficient and meets the regulatory requirements.
    1. You're the right fit if:
  1. You have a Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  2. You have minimum 5 years of CAPA experience in highly regulated environments/industries such as medical devices, Pharma, Automotive.
  3. You have minimum 3 years of experience in managing product and/or process risk assessments per ISO 14971
  4. You have led quality improvement projects on cost of non/poor quality
  5. You have a proactive and entrepreneurial mindset, and act fast on potential issues.
  6. You have extensive experience in working with commercial functions and service/installation functions within the organization.
  7. You are able to deal with stakeholders and teams based globally.
  8. You have ASQ CQA, CQE or similar credentials (e.g., Lead Auditor, Lean, Six Sigma) acceptable.

CAPA Consultant · Apolis

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