Medical Device QA Engineer - Design Controls & Validation

Physiol; Roma; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

Physiol in Rome is seeking a Quality Engineer to support product and process quality objectives within the medical device industry. The role involves quality assurance, compliance with regulatory standards, and improving product design.

Qualified candidates will have expertise in FDA and ISO regulations, strong communication skills, and hands-on experience in a laboratory environment. A BS in engineering is required, and an MS is preferred. Interested applicants should be fluent in both Italian and English.

Competenze

• In depth familiarity with FDA, ISO, MDD/MDR and quality requirements for product development.
• Detailed understanding of US and International regulations including 21CFR820.
• 5-7+ years of medical device engineering experience preferred.

Mansioni

• Identify manufacturing process defects and implement corrective actions.
• Monitor systems and reduce process variation.
• Evaluate new equipment and participate in new product transfers.

Conoscenze

Fluent in Italian and English

Strong communication and presentation skills

Competent with Microsoft Office Suite

Experience in electro-optical systems development

Hands-on experience in a laboratory setting

Formazione

BS in Mechanical, Electrical, or Biomedical Engineering

MS strongly preferred

Strumenti

Minitab Statistical Analysis software

Descrizione del lavoro

Physiol in Rome is seeking a Quality Engineer to support product and process quality objectives within the medical device industry. The role involves quality assurance, compliance with regulatory standards, and improving product design.

Qualified candidates will have expertise in FDA and ISO regulations, strong communication skills, and hands-on experience in a laboratory environment. A BS in engineering is required, and an MS is preferred. Interested applicants should be fluent in both Italian and English.