CAPA Consultant

CAPA Consultant

Location:

Cambridge MA

Tax Term (W2, C2C):
Any

Job Type (Permanent/Contract):
Contract

Duration: 6+ months

Pay Range: $40 - $45/hr

• 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.

• You have a Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• You have minimum 5 years of CAPA experience in highly regulated environments/industries such as medical devices, Pharma, Automotive.
• You have minimum 3 years of experience in managing product and/or process risk assessments per ISO 14971
• You have led quality improvement projects on cost of non/poor quality
• You have a proactive and entrepreneurial mindset, and act fast on potential issues.
• You have extensive experience in working with commercial functions and service/installation functions within the organization.
• You are able to deal with stakeholders and teams based globally.
• You have ASQ CQA, CQE or similar credentials (e.g., Lead Auditor, Lean, Six Sigma) acceptable.