Sr Quality Complaints Engineer

Our hiring company, a best in class medical device manufacturer has an opening for a Senior Complaint Investigator Engineer (Hybrid) north of Baltimore on the Delaware border.

Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 100 years and has been rated as Forbes top 14 most innovative companies in the world.

With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to society.

The Senior Complaint Investigator Engineer will be responsible for investigating and resolving product complaints to ensure product safety and regulatory compliance.

The Engineer will work closely with cross-functional teams to analyze complaint data, identify root causes, and implement corrective actions to enhance product quality and reliability.

Day-to-Day Duties May Include :

• Leading the failure investigation of products by analyzing data, conducting root cause analyses, and implementing corrective and preventive actions (CAPAs) to address identified issues.
• Ensuring complaint investigations comply with FDA regulations, ISO standards, and other relevant regulatory requirements.
• Preparing and reviewing documentation related to complaint investigations and regulatory submissions.
• Analyzing complaint data and trends to identify potential product issues, assess risk, and recommend improvements to product design and manufacturing processes.
• Collaborating with engineering, manufacturing, and R&D teams to address and resolve complaint-related issues.
• Facilitating communication and ensuring that corrective actions are effectively implemented.
• Preparing detailed investigation reports and presentations for internal stakeholders and regulatory agencies.
• Providing insights and recommendations based on investigation findings.
• Contributing to the development and enhancement of complaint handling processes and procedures.
• Supporting initiatives to improve overall product quality and customer satisfaction.
• Providing guidance and training to team members on complaint investigation processes and best practices.
• Mentoring junior engineers and supporting 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