Senior Complaint Investigator Engineer

1 day ago

Elkton, Minnesota, United States JBL Resources Full time
Job Title: Senior Complaint Investigator Engineer

Our company, a leading medical device manufacturer, is seeking a highly skilled Senior Complaint Investigator Engineer to join our team. With a strong commitment to quality and excellence, we have been a trusted partner in the healthcare industry for over 100 years.

Job Summary:

The Senior Complaint Investigator Engineer will be responsible for investigating and resolving product complaints to ensure product safety and regulatory compliance. This role will work closely with cross-functional teams to analyze complaint data, identify root causes, and implement corrective actions to enhance product quality and reliability.

Key Responsibilities:
  • Lead the failure investigation of products by analyzing data, conducting root cause analyses, and implementing corrective and preventive actions (CAPAs) to address identified issues.
  • Ensure complaint investigations comply with FDA regulations, ISO standards, and other relevant regulatory requirements.
  • Prepare and review documentation related to complaint investigations and regulatory submissions.
  • Analyze complaint data and trends to identify potential product issues, assess risk, and recommend improvements to product design and manufacturing processes.
  • Collaborate with engineering, manufacturing, and R&D teams to address and resolve complaint-related issues.
  • Facilitate communication and ensure that corrective actions are effectively implemented.
  • Prepare detailed investigation reports and presentations for internal stakeholders and regulatory agencies.
  • Provide insights and recommendations based on investigation findings.
  • Contribute to the development and enhancement of complaint handling processes and procedures.
  • Support initiatives to improve overall product quality and customer satisfaction.
  • Provide guidance and training to team members on complaint investigation processes and best practices.
  • Mentor junior engineers and support their professional development.
Qualifications:
  • Bachelor's degree in Engineering or a Scientific discipline required.
  • Master's degree in science or engineering preferred.
  • A minimum of 5 years of complaint investigation experience.
  • Medical Device industry experience required - extensive knowledge of FDA regulations, ISO 13485, EU MDR, MDSAP, and other relevant industry standards related to complaint handling and product quality.
  • Hands-on failure investigation of used products, mechanical aptitude.
  • Proven experience in using root cause analysis tools, such as Fishbone Diagrams, 5 Whys, and Failure Mode and Effects Analysis (FMEA).
  • Strong organizational skills with the ability to manage multiple investigations and prioritize tasks effectively.

Interested candidates please apply on our website at https://jobs.jblresources.com. For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com. JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

JBL is an Equal Opportunity Employer and E-Verify Company.

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