Quality Engineer III

• Responsible for ensuring compliance with EUMDR Class II & III requirements, supporting supplier validation assessments, driving quality improvements, and overseeing process validation, CAPA, and risk management activities within a regulated manufacturing environment.

Requirement/Must Have:

• Bachelor s degree with 8+ years of experience, or Master s degree with 5+ years of experience, or Doctoral degree with 3+ years of experience.
• Experience working in manufacturing or operations environment.
• Strong knowledge of product and process risk management aligned with FDA and ISO standards.
• Experience in implementing risk mitigation strategies in regulated environments.
• Strong technical understanding of manufacturing equipment and processes.

Experience:

• Experience working on EUMDR Class II and Class III compliance projects.
• Experience assessing supplier validations and identifying compliance gaps.
• Experience in process validation activities and remediation support.
• Experience conducting IQ, OQ, PQ, TMV, and software validations.
• Experience with process monitoring and control methods for product and process risk levels.
• Experience with data collection, statistical analysis, and process improvement initiatives.
• Experience handling nonconformances, CAPA, and customer complaint investigations.
• Experience in root cause analysis and preventive/corrective action effectiveness reviews.
• Experience in manufacturing material identification, segregation, and defect classification.

Responsibilities:

• Work within cross-functional teams to assess supplier validations and ensure compliance with EUMDR requirements.
• Identify and support remediation of supplier gaps related to process validation.
• Support quality improvement initiatives for process and product characterization.
• Conduct benchmarking activities to improve quality systems and processes.
• Approve IQ, OQ, PQ, TMV, and software validation documentation.
• Develop and implement process monitoring and control methods based on product risk.
• Collect and analyze data using statistical and analytical methods.
• Lead investigations of nonconformances, CAPA, and customer complaints.
• Escalate quality issues as required based on severity and impact.
• Ensure proper material identification, segregation, and defect classification in manufacturing.
• Evaluate effectiveness of corrective and preventive actions.
• Review root cause analyses following established processes.
• Support additional special quality engineering projects as assigned.

Should Have:

• Strong analytical and problem-solving skills.
• Strong attention to detail in documentation and compliance activities.
• Ability to work effectively in cross-functional teams.
• Strong communication and documentation skills.

Skills:

• EUMDR Class II & III compliance.
• Process validation (IQ, OQ, PQ, TMV).
• FDA and ISO quality systems.
• Risk management in manufacturing processes.
• CAPA and nonconformance management.
• Root cause analysis.
• Statistical and data analysis techniques.
• Supplier validation assessment.
• Quality improvement and process characterization.

Qualification And Education:

• Bachelor s degree or equivalent experience with 8+ years of relevant experience, or Master s degree with 5+ years, or Doctoral degree with 3+ years.