Remote Product Quality Engineer Job in Sacramento, CA Agilent Technologies

Who you are

• Bachelor’s or Master’s Degree in engineering science or related technical field.
• 4+ years of relevant experience in a regulated industry such as medical device biopharmaceutical or pharmaceutical.
• Experience with regulations and standards such as ISO 13485 FDA CFR 21 Part 820 and ISO 14971.
• Skill in risk determinations from FMEAs and other Risk documents.
• Ability to lead and contribute to root cause investigations and assess corrective action effectiveness.
• Experienced in driving and owning root cause analysis Corrective Action / Preventive Action (CAPA) Non-Conformance or Supplier Corrective Action investigations to timely closure.
• Proficient in tools and methods like Six Sigma and Lean for process and business improvements.
• Ability to review and approve complex CAPA issues for audit readiness.
• Process and detail oriented proactive team player with cross-functional collaboration skills.