Service Quality Engineer

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Service Quality Team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization.

The Service Quality Engineer will be technical, hands-on and customer-focused, with an ability to analyze, 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.

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 on-site role in our Madison, NJ facility.

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  
• Analyze and trend on product performance data to provide recommendations for product improvements
• 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

·       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
• Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities
• 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 and 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.

Requirements

Skills & Experience

• Excellent technical report writing skills
• Strong Root Cause Analysis, Design of Experiments, and test method development 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
• 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
• 3-5 years of related hands-on engineering experience in the medical device industry, or equivalent.
• Ability to travel 10-20% (including 3-4 visits per year to Oxford and to suppliers/contract manufacturers in the US and/or Europe)
• 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
• Experience in an FDA regulated environment is a plus

#LI-Onsite 

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

Benefits

The Pay Range for this position is $105,000 - $115,000 annually, with a 10% target annual bonus and benefits.

At OrganOx, we offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides 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.