Product Quality Engineer

Position Summary

The Product Quality Engineering team at Organ Ox is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the Organ Ox Metra, a Class III medical device. The team works closely with Product Sustaining Engineering and Contracted Suppliers to establish quality control and management processes for externally built products and components, including sterilization and microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer position is focused on hands‑on complaint investigation of returned product. This role is ideal for an entry‑level engineer looking to grow and develop quality engineering skills. The ideal candidate will have prior laboratory or investigation experience and the 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.

This is a flexible, on‑site role in our Madison, NJ office.

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.

• Support root‑cause investigations in response to customer complaints.
• Support hands‑on analyses of returned products to identify root causes of failures.
• Receive all returned products and perform full decontamination process in accordance with established procedures.
• Gather all relevant case details, including service reports, system data, and clarifying information, to support a thorough complaint evaluation.
• Execute hands‑on lab work such as monitoring running test circuits or preparing equipment for evaluation.
• Support development of investigation criteria and test methods to properly diagnose and root cause field failures.
• Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends and support timely closure of SCARs.
• Work cross‑functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.
• Support CAPAs, escalations, and engineering investigations in response to field 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 Organ Ox’s Code of Conduct and all other company policies.

• Familiarity with quality engineering principles such as complaint investigation, SCARs, and CAPAs.
• Experience handling laboratory materials and conducting hands‑on lab investigations.
• Excellent oral and written communication skills, with the ability to communicate with audiences of varying technical skill.
• Strong organizational skills with the ability to manage multiple tasks simultaneously.
• Ability to prepare written technical plans and reports documenting failure investigations.
• Proven ability to work cross‑functionally and within global teams, fostering a culture of high collaboration.
• Self‑driven, able to solve complex problems independently, and committed to upholding Organ Ox values in daily work and decision‑making.
• Experience driving a global quality mindset across teams and geographies.
• 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 equivalent work experience.
• 0–2 years of related hands‑on engineering experience in medical devices, pharmaceuticals, or other regulated industry.
• Excellent technical report writing skills.
• Strong experience with MS Office products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.).
• Prior experience performing complaint investigations (preferred).
• Ability to travel 10–20 % (domestically and internationally).

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

At Organ Ox, 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. Organ Ox supports work‑life balance and provides opportunities for ongoing professional development.