What are the responsibilities and job description for the Associate Quality Engineer position at Paragonix Technologies, Inc?
Job Description
Job Description
Description Introduction
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 : As an Associate Quality Engineer, you will work closely with cross-functional teams to support various aspects of quality engineering, with a focus on New Product Introduction and failure analysis. Reporting to the Manager, Quality Engineering, you will assist in implementing and maintaining quality systems and processes to meet regulatory requirements and industry standards.
Primary responsibilities / authority will include :
50% - New Product Introduction
Assist in integrating quality requirements into new product development introduction / transfer processes.
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.
Collaborate with product development teams to ensure compliance with regulatory standards during design transfer phases.
Participate in risk assessments and contribute to risk management activities for new products.
30% - Failure Analysis
Generate, review, and maintain Quality records in support of the Post Market Surveillance System, e.g., Customer Feedback, NC, and CAPA.
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.
Assist in analyzing post-market data to identify opportunities for product improvements.
20% - Quality Operations
Support quality systems and processes, including document control and change management.
Contribute to ensuring compliance with FDA regulations and international quality standards.
Assist in monitoring key quality metrics and participating in investigations into deviations and non-conformances.
Required Qualifications :
Bachelor's Degree in an engineering or scientific discipline.
Minimum 1 year of direct experience in a medical device or manufacturing setting.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Preferred Qualifications :
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.
Experience with risk management methodologies (e.g., FMEA).
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.
Other Requirements :
Location : Onsite Hybrid – 3 days per week
Able to travel domestically and internationally as required (
Able to work in the US without sponsorship now or any time in the future.
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