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OrganOx · 2 days ago

Product Quality Engineer

Madison, NJ

Full-time

Onsite

Mid, Senior Level

$100K/yr - $110K/yr

3+ years exp

OrganOx is an innovative global medical device company focused on improving transplantation outcomes through advanced technology. They are seeking a motivated Product Quality Engineer to analyze product quality issues, improve product performance, and ensure compliance with quality standards.

Health CareMedicalMedical Device

Responsibilities

Conduct hands-on analyses of returned 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 or Non-Conformance 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

Foster supplier relationships and support Supplier corrective action requests

Support Product Transfer teams by aligning on quality requirements and 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, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards

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

Qualification

Root Cause AnalysisTest Method DevelopmentFDA QSR KnowledgeStatistical AnalysisTroubleshooting Electro-Mechanical SystemsTechnical Report WritingCommunication SkillsAttention to DetailCross-Functional CollaborationCustomer Focus

Required

Excellent technical report writing skills

Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to Service activities and complaint or non-conformance investigations

Experience in leading investigations and trending analysis, leveraging expertise in troubleshooting electro-mechanical systems and engineering custom test fixtures and apparatuses for functional and performance validation

Ability to manage multiple investigations and projects independently

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

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

Bachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience

3-7 years of related hands-on engineering experience in the medical device industry, or equivalent

Ability to travel 10-20%

Strong background in troubleshooting electro-mechanical systems and interpreting electrical schematics and circuit diagrams

Experience using diagnostic tools such as digital multimeters and oscilloscopes, as well as developing and validating test methods for components including PCBs, motors, pumps, power supplies, and batteries

Prior experience in implementing new processes and driving improvements