Validation Engineer - Bethany, United States - Sapphire Enterprises

Sapphire Enterprises

Verified Company

Bethany, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

Do you want to contribute your expertise in the validation of medical devices? Do you have experience in the medical technology field? Then join us immediately as a Validation Engineer (m/f/d) in Baden-Württemberg, supporting Bethany.

Your responsibilities:

Leading and implementing validation and revalidation projects, both internally and with external suppliers.
Developing test plans and inspection plans, as well as conducting final inspection qualifications and training for inspectors.
Planning, implementing, and evaluating process reviews with suppliers.
Serving as a liaison for suppliers and internal departments regarding quality matters; potentially implementing quality circles and process optimizations.
Initiating and coordinating the partial release process.
Assisting with internal and external audits.

Requirements:

Completed engineering degree (mechanical engineering, automation engineering, medical technology, pharmaceutical technology, or similar).
Experience in qualification and validation.
Professional experience in the medical technology field.
Knowledge of current Good Manufacturing Practice (GMP) and regulatory requirements in the medical technology field (ISO13485, MDSAP).
Experience and knowledge in FMEA and statistics.

I look forward to receiving your application documents (CV,