Found Description
We are seeking a **Quality Engineering Lead** with strong expertise in **metrology** to lead quality systems and ensure compliance within a **medical device manufacturing environment**.
This role will be responsible for driving measurement excellence, supporting validation activities, and ensuring compliance with regulatory standards such as FDA and ISO.
**Key Responsibilities**- Lead and mentor the **Quality Engineering team**:- Oversee and improve **metrology systems** (CMM, vision systems, calibration programs)- Ensure compliance with **FDA regulations, ISO *****, and GMP requirements**:- Support and lead **validation activities** (IQ, OQ, PQ)- Drive **process capability analysis (Cp, Cpk)** and continuous improvement initiatives- Lead **root cause investigations** and CAPA implementation- Develop and maintain **inspection methods, control plans, and quality documentation**:- Partner with Manufacturing, Engineering, and Operations to ensure product quality and compliance-...