Job Specifications
ABOUT ORGANOX:
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 Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.
The Product Quality Engineer will have strong technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.
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 Oxford, with flexibility.
Major Responsibilities
Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:
Analyze and trend on product performance data to provide recommendations for product improvements
Raise Supplier Corrective Action Reports (SCARs) and Nonconforming Material Reports (NCs) in response to product performance trends
Support root cause investigation and timely closure of SCARs and NCs
Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.
Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
Supports updates to supplier quality agreements
Support validation of new processes at suppliers
Support hands-on analyses of returned products to identify root causes of failures
Support development of investigation criteria and test methods to properly diagnose and root cause field failures
Provide technical insight to sterilization and microbiological processes
Support CAPAs, Escalations, and engineering investigations in response to product quality issues.
Participate in the development and review of engineering change orders that impact product quality activities
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
Requirements
Skills & Experience
Demonstrable related hands on engineering experience in the medical device industry, or equivalent
Knowledge of medical device sterilization and microbiology preferred
Excellent technical report writing skills
Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to complaint investigations
Experience investigating and resolving SCARS and CAPAs
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
Proven ability to work cross functional and within global teams, fostering a culture of high collaboration.
Ability to be self driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making.
Experience in driving a global quality mindset across teams and geographies.
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
Ability to travel 10-20%
Familiarity with ISO14971 and associated Risk Management Processes is
About the Company
"Living Organs For Life"
Transforming transplantation with the OrganOx metra®. A transportable, automated ex vivo liver perfusion device.
The core technology employed by the OrganOx metra® has been in development for over 15 years. During this time both of the founders (Professor Peter Friend and Professor Constantin Coussios) have driven the development of organ preservation and maintenance, formerly at the University of Cambridge and latterly at the University of Oxford.
OrganOx Limited was founded in April 2008 as a spi...
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