Service Quality Engineer

OrganOx, a pioneering medical device company founded in 2008, is revolutionizing organ transplantation with its flagship product, the OrganOx metra®. This innovative technology preserves donor livers for up to 12 hours, aiming to reduce organ discard rates and improve transplant success. As part of their expansion in North America, OrganOx is seeking a motivated Service Quality Engineer to join their team.

The Service Quality Engineer will play a crucial role in maintaining quality processes within the Service organization, including the Service Depot, Field Service, and International Service. Key responsibilities include:

1. Auditing and reviewing complaint investigations and servicing activities records
2. Developing investigation criteria and prior investigation summaries
3. Conducting analyses of serviced products to identify root causes of failures
4. Performing Service-related PFMEAs and supporting risk management activities
5. Quality trending of Service data and investigating causes of servicing and complaint trends
6. Providing training to Service staff on regulatory requirements
7. Participating in Product Transfer teams to develop service repair processes
8. Conducting Service Manual and work instruction validations
9. Reviewing and developing engineering change orders impacting servicing activities
10. Designing and implementing tooling and fixturing for servicing activities
11. Performing DHR, Service History record, and PFMEA reviews for complaint investigations

The ideal candidate should have:

• A Bachelor's degree in an Engineering discipline or equivalent work experience
• 2-6 years of related quality engineering experience
• Strong technical report writing skills and root cause analysis experience
• Understanding of FDA QSR Quality System Requirements
• Proficiency in MS Office products
• Excellent communication skills
• Ability to travel 10-20%
• Knowledge of electro-mechanical troubleshooting techniques

OrganOx offers a competitive compensation package, comprehensive benefits including healthcare and retirement plans, and opportunities for professional development. They value innovation, evidence, integrity, teamwork, respect, and passion, and are committed to maintaining a work-life balance for their employees.

Join OrganOx in their mission to improve transplantation outcomes and make a significant impact in the field of medical technology.