Quality Engineer

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position Overview: The Quality Engineer plays an integral role in Paragonix's Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals.

Primary responsibilities/authority will include:

40% - Failure Analysis

• Generate, review, and maintain Quality records in support of the Post Market Surveillance System, e.g., Customer Feedback, NC, and CAPA.
• Conduct product testing, failure analysis, and troubleshooting for new failure modes.
• Perform investigation triage, deep dive investigations, and assume accountability for quality investigations, root cause analysis, aiming to develop hypotheses for failure.
• Collect log quality data and trend results.
• Prepare visualizations and conclusions based on product field performance for presentation to upper management.

30% - QA Operations

• Partner with Quality Assurance and other team members to ensure effective inspection and testing procedures are implemented and maintained.
• Partner with engineering groups in Manufacturing and R&D to perform root cause analysis on complex failures and trends.
• Review Lot Acceptance records and DHRs, create trend charts.
• Participate in the successful completion of FMEAs, Process Flow analysis, Control Plans, Measurement Systems Analysis and Process Capability Analysis
• Perform supplier quality management such as supplier approval, supplier auditing, supplier evaluation and maintenance of approved supplier list.
• Introduce supplier quality methods/procedures that might be new for the organization.
• Support facility audits by outside agencies (i.e., FDA, BSI)

20% - Quality Systems

• Implement, manage, and drive continuous improvement in change control processes to ensure that changes to products, processes, or systems are documented, reviewed, and approved in accordance with established procedures.
• Maintain the organization's digital training platform that ensure compliance with applicable regulations and enhance employee competency in the Quality System.
• Collaborate with cross-functional teams to assess the impact of proposed changes and ensure compliance with regulatory requirements.

10% - New Product Introduction

• Coordinate with R&D, Product Management, and Operations departments to allow successful transition from product release to production readiness.
• Evaluate validation plans, product monitoring processes, and supply chains for compliance and effectiveness during the Design Transfer phase of the product lifecycle.
• Perform other duties as assigned.

Required Qualifications:

• Bachelor's Degree in an engineering or scientific discipline.
• 1-3 years of direct experience in a medical device setting.

Other Requirements:

• Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485.
• Electrical and mechanical background strongly preferred.
• Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
• Computer proficiency in MS office (specifically Excel).
• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred.
• Effective verbal and excellent technical writing skills.
• Excels at generating and maintaining organized and accurate records.
• Excellent oral and written communication skills in English.
• Able to travel domestically and internationally as required (<10%)
• Able to work in the US without sponsorship now or any time in the future.