Skip to main content

Test Method Validation Engineer

Employer
Katalyst Healthcares & Life Sciences
Location
Campbell, CA
Closing date
Sep 14, 2024

View more

Responsibilities:

Conducting and overseeing test method validation, ensuring adherence to quality standards.

Designing and implementing protocols for validation processes.

Managing and navigating documentation effectively.

Qualifying test fixtures using IQ, OQ, and PQ.

Using statistical knowledge to select appropriate samples and run small characterizations.

Working hands-on in the lab and directly with technicians.

Collaborating with the development team to optimize processes.

Documenting and reporting any failures or anomalies in the verification and validation process immediately.

The successful candidate will be responsible for navigating test method validation in our quality system, designing protocols, and managing documentation.

They will also be hands-on in the lab, qualifying test fixtures using Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Proficiency in statistics, including sample selection, small characterizations, and standard gauge R&R is necessary for this role.

Requirements:

7+ years of experience Broad knowledge across multiple disciplines including firmware, thermal, optical, software, and electrical.

Strong statistical skills and the ability to conduct standard gauge R&R.

Excellent documentation and protocol design skills.

Proficiency in test fixture qualification IQ, OQ, PQ.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert