Quality Engineer – Medical Device, 21 CFR 820 (On-site)

Mindlance; West Chester (Chester County); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device firm is seeking a Quality Engineer in West Chester, PA. The role involves ensuring compliance with quality systems for drug injection devices while collaborating with global teams. The ideal candidate should have a BA/BS degree and 5+ years of related experience. Responsibilities include monitoring compliance with regulations and improving product quality through established procedures. This is an on-site position with potential for extension.

Qualifications

• 5+ years of experience in quality engineering or related field.
• Familiarity with drug injection device design control processes.
• Experience with quality audits and standard operating procedures.

Responsibilities

• Ensure compliance with CMO policies and quality management processes.
• Monitor and improve product quality and supplier processes.
• Communicate with device development and compliance teams internationally.

Skills

Quality System compliance

Knowledge of 21 CFR Part 820 regulations

Analytical problem-solving

Process improvement

Education

Undergraduate/BA/BS degree in applicable discipline

Job description

A leading medical device firm is seeking a Quality Engineer in West Chester, PA. The role involves ensuring compliance with quality systems for drug injection devices while collaborating with global teams. The ideal candidate should have a BA/BS degree and 5+ years of related experience. Responsibilities include monitoring compliance with regulations and improving product quality through established procedures. This is an on-site position with potential for extension.