Sr Quality Engineer, Critical Systems

Fresenius Kabi AG

$95K — $115K *
Manufacturing & Automotive
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in manufacturing and quality assurance
  • Familiarity with regulatory compliance standards
  • Proficiency in statistical analysis techniques
  • Strong technical writing skills for documentation
  • Experience with validation processes and procedures

Responsibilities

  • Develop and evaluate manufacturing quality standards
  • Investigate validation discrepancies and troubleshoot issues
  • Conduct statistical analyses of test results
  • Write and review documentation for validation procedures
  • Ensure corrective actions meet reliability standards
  • Verify maintenance and calibration of manufacturing instruments

Benefits

  • Medical, dental, and vision coverage
  • Life insurance and disability coverage
  • 401K with company contribution
  • Wellness program support
Full Job Description
Job Summary

Develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analysis, and verifies instrument maintenance, potentially assisting in establishing corporate validation policies.

Responsibilities

The Professional performs some or all of the following accountabilities as assigned:
• Developing and evaluating quality and system standards to ensure reliability and compliance with company standards and governmental regulatory requirements
• Investigating/troubleshooting validation discrepancies for systems and/or performance processes
• Conducting statistical analyses of testing results and process anomalies
• Writing, reviewing, approving and/or executing documentation for new and current validation procedures and technical reports related to systems, products and/or processes
• Ensuring corrective measures meet acceptable reliability standards
• Verifying calibration, maintenance and repair of instruments

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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