Quality Assurance Engineer

Datwyler Group

Quality Engineer at Datwyler ensuring compliance with regulatory requirements and supporting manufacturing processes. Collaborating to drive continuous improvement initiatives in a regulated environment.

Posted 5/4/2026full-timeMiddletown • 🇺🇸 United StatesJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
Participate in PFMEA, Control Plans, and risk management activities.
Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
Support quality planning and risk assessments for new products and transfers.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Quality, Science, or a related discipline.
2–5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
Experience with molding or precision manufacturing processes preferred.
Strong knowledge of ISO 13485, FDA 21 CFR 820, Risk management (ISO 14971), Process validation.
Experience with statistical tools and SPC.
Proficiency in MS Office; experience with eQMS systems is a plus.

Benefits

Comp & perks

Health insurance
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality engineeringprocess validationstatistical toolsSPCrisk managementmolding processesprecision manufacturingISO 13485FDA 21 CFR 820ISO 14971