Quality Engineer, Medical Devices & CAPA Lead

NIPRO Corporation - Global; Lewisberry (PA); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading medical device firm is seeking a Quality Engineer responsible for overseeing quality projects and ensuring compliance with industry standards. The role involves collaborating with manufacturing on process improvements, leading investigations, and maintaining documentation compliance. Candidates should hold a bachelor's degree in a relevant field and have over 5 years of experience in the medical devices industry. Excellent communication and organizational skills are essential for this position.

Qualifications

• 5+ years’ experience in medical devices, quality, or manufacturing.
• Knowledge of FDA regulations and quality standards.

Responsibilities

• Utilize Quality Engineering principles to develop process controls.
• Partner with manufacturing to implement process improvements.
• Lead product design changes and risk management activities.
• Collaborate with Quality Laboratory for process improvements.
• Maintain compliance with all company policies.

Skills

Excellent computer proficiency (MS Office)

Excellent verbal and written communication

Ability to work under pressure

Independent work ability

Education

Bachelor's degree in Life Sciences or technical discipline

Tools

FDA 21 CFR 820

ISO 13485

ISO 14971

cGMP

Job description

A leading medical device firm is seeking a Quality Engineer responsible for overseeing quality projects and ensuring compliance with industry standards. The role involves collaborating with manufacturing on process improvements, leading investigations, and maintaining documentation compliance. Candidates should hold a bachelor's degree in a relevant field and have over 5 years of experience in the medical devices industry. Excellent communication and organizational skills are essential for this position.