ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Service Quality Engineer to join our team.

Position Summary

The Service Quality Engineer is responsible for the Quality processes within the Service organization, including the Service Depot, Field Service and/or International Service. This individual will be technical, hands-on, and customer focused with an ability to diagnose and test product quality issues. The successful candidate is collaborative, has excellent communication and problem solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. The Service QE will be responsible to review the output of Servicing and related Complaint Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is an in-office role in our Madison, NJ facility to ensure effective control of the manufacturing and service documentation, and collaboration with both the Operations and Quality teams; this will be agreed with the QC Team Leader or Manager.

Requirements

Major Responsibilities

Under direction from the Service Quality Manager, the Service Quality Engineer will be responsible for:

Conduct hands on analyses of serviced products to identify root causes of failures
Develop investigation criteria and test methods to properly diagnose and root cause field failures

The Service QE will be responsible to review the output of Servicing and related Complaint Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.

Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.
Develop investigation criteria and prior investigation summaries
Conduct analyses of serviced products to identify root causes of failures
Perform Develop Service-related PFMEAs and other activities to support pre-market and post-market risk management activities
Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures.
Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records
Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products
Plan, develop and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations,
Participate in the development and review of engineering change orders that impact servicing activities
Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations
Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures.
Support CAPAs, Escalations, and engineering projects in response to field quality issues.
Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities.

Skills and Experience

Excellent technical report writing skills
Strong Root Cause Analysis, and Design Of Experiments, and test method development /Investigation experience as related to Service activities and complaint investigations
A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
Strong experience with statistical analysis of data. Experience with Minitab preferred.
Experience with Six Sigma principles preferred.
Experience with SolidWorks preferred.
Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
Strong focus on meeting customer needs.
Ability to work with cross-functional teams.
Ability to be self-driven and solve complex problems independently.
Demonstrated strong attention to detail and “do it right the first time” attitude

Qualifications

Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience
1-3 2-6 years of related quality engineering (QE) work experiencehands on engineering experience in a regulated industry. Experience with medical devices preferred.
Ability to travel 10-20%
Knowledge of electro-mechanical troubleshooting techniques
Experience in a customer focused Service organization is a plus
Familiarity with ISO14971 and associated Risk Management Processes is a plus
Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus
Ability to lift, push, or pull up to 50 pounds
Experience in an FDA regulated environment is a plus

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Employees will be required to follow any other job-related instruction as requested by their manager.

WHAT WE OFFER:

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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