Quality Engineer

We are a growing patient-centric medical device company developing the next generation of hydraulic drug delivery systems.

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.

Our mission is to improve patient quality of life by ensuring life-saving injectable medications are available anytime, anywhere.

With a presence in virtually every country, we tackle some of the most challenging global health issues affecting patient access to treatments.

Our team is highly cross-functional and deeply passionate about innovation.

Every perspective is encouraged, and initiative is expected.

As a Quality Engineer, you will be a respected and valued member of our technology team, directly contributing to the safety, reliability, and effectiveness of products that change lives.

Position Overview The Quality Engineer will play a critical role in ensuring compliance with medical design controls, regulatory requirements, and product quality standards.

You will be responsible for writing protocols, assisting in qualifying our Denville laboratory, calibrating and maintaining testing equipment, monitoring qualifying events at our laboratory and manufacturing partners, and reviewing batch releases.

Responsibilities Apply working knowledge of medical design controls and regulatory requirements.

Develop and implement quality procedures across incoming, in-process, final inspection, and release activities.

Interpret engineering drawings to define gauging methods; perform first article and dimensional inspections.

Initiate release of material to manufacturing and maintain GMP documentation.

Manage the calibration system, perform calibrations, and execute preventive maintenance on equipment, fixtures, and gauges.

Maintain training files, calibration logs, and other GMP quality records.

Collect and analyze quality data; prepare quality reports and support management reviews.

Support internal audits and other quality system requirements.

Execute and monitor lab testing as required.

Collaborate with cross-functional teams, manufacturing partners, and suppliers on quality-related issues.

Perform other duties as assigned to ensure operational excellence.

Qualifications Experience Minimum 8 years of hands-on inspection experience, preferably in medical devices or equivalent regulated industries.

Strong background in quality systems (ISO 9000, FDA QSR).

Experience with system documentation and maintaining GMP compliance.

Proficiency in MS Excel, Word, and familiarity with statistical analysis; specialized statistical software preferred.

Solid mathematics and statistical analysis skills.

Certifications such as CMI (Certified Mechanical Inspector) or CQT (Certified Quality Technician) preferred.

Education High school diploma or higher education in a relevant discipline.

Strong math skills are essential.

Physical Demands Ability to perform light lifting (up to 20 lbs).

Ability to stand for extended periods (up to 4 hours).

Willingness to travel periodically (~5%) for supplier audits and project support.