Process Validation Engineer Medical Devices

Los Angeles, CA, US • Posted 1 day ago • Updated 16 hours ago
Contract Independent
Contract W2
12 Months
No Travel Required
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • Validation Engineer
  • Process Improvement
  • Medical Device
  • Healthcare
  • Process Validation Engineer

Summary

Job Description:

We are seeking a Process Validation Engineer with experience in the Medical Device or Healthcare domain. The ideal candidate will be responsible for planning, executing, and documenting process validation activities to ensure manufacturing processes consistently produce products that meet quality and regulatory requirements.

 

Key Responsibilities:

  • Develop and execute process validation protocols (IQ, OQ, PQ).
  • Support manufacturing process improvements and process transfers.
  • Ensure compliance with FDA, ISO 13485, and GMP regulations.
  • Prepare validation documentation, reports, and risk assessments.
  • Collaborate with Quality, Manufacturing, and Engineering teams.
  • Investigate process deviations and implement corrective actions.
  • Support audits and regulatory inspections.

 

Required Skills:

  • 3+ years of experience in Process Validation within the Medical Device or Healthcare industry.
  • Strong knowledge of IQ/OQ/PQ, GMP, FDA, and ISO 13485 requirements.
  • Experience with validation documentation and change control processes.
  • Excellent analytical, problem-solving, and communication skills.
  • Bachelor’s degree in engineering or a related field.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 9007612
  • Posted 1 day ago
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AK

Anuradha Karod

Recruiter @ Talent Groups
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