CAPA Technical Lead
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CAPA Technical Lead
Ref No.: 18-32506
Location: Somerville, New Jersey
Position Type:Direct Placement
Experience Level: 10 Years
Start Date: 05/10/2018
 
  • Lead and/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
  • Lead and/or participate in cross-geo CAPA project teams
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
  • Experience in medical device, pharmaceutical and/or a comparable regulated environment
  • Subject Matter Expert / Expertise in leading effective root cause investigation, corrective and preventive action planning and execution, and verification of effectiveness.
  • Excellent understanding of FDA regulations (21 CFR 820 and Part 11), ISO 13485.
  • CAPA documentation systems experience (e.g. Trackwise)
  • Experience generating and reviewing technical documentation
  • Strong analytical and decision making skills
  • Experience with quality tools and process improvement techniques
  • Excellent written and verbal communication skills
  • Excellent project Management Skills.