Job Details

ID #1428372
State California
City San francisco bay area
Full-time
Salary USD TBD TBD
Source California
Showed 2018-11-26
Date 2018-11-23
Deadline 2019-01-22
Category Science/biotech
Create resume

Associate Quality Engineer/Quality Engineer (san jose north)

California, San francisco bay area 00000 San francisco bay area USA

Vacancy expired!

San Jose based Click Diagnostics is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Click is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.

We have a talented team of researchers, biologists, designers, engineers, and operations and administrative resources team. If you are passionate about making a difference, thrive on tackle challenging problems, and want to join a collaborative ownership team that will change the world of healthcare, please consider the following:

Associate Quality Engineer/ Quality Engineer. Position will report to the Director of Quality and Regulatory and work a swing shift from 3 pm - 11 pm.

The successful candidate is an enthusiastic, self-motivated individual with great communication skills who can support the development, implementation, and management of the Quality Management Systems to ISO 13485 and FDA QSR. The Quality Engineer will demonstrate a high level of individual responsibility and accountability.

Core responsibilities will include, but not be limited to:

Creating, updating, reviewing and developing Quality Management System standard operating procedures

and supporting work instructions per ISO 13485 and FDA QSR.

Assisting personnel in use of Quality systems, tools, and techniques based on ISO 13485 and FDA QSR.

Performing root cause data analysis using statistical techniques.

Writing and performing qualification, verification/validation protocols under limited supervision.

Supporting the Internal Audit and Supplier Quality programs.

Providing support to manufacturing through batch record review and approval and on-line troubleshooting.

Education, Experience & Personal Qualities

BS in a STEM field or equivalent combination of education and/or experience is required; Molecular Biology, Engineering, or related discipline strongly preferred.

One to two years' experience in a FDA regulated Medical Device industry required; Diagnostics experience preferred.

Start-up experience beneficial.

Professional certification in Quality Auditing, Quality Engineering, and/or Quality Management preferred.

Proactive approach, with high sense of urgency and results orientation.

Strong interpersonal skills, demonstrated ability to interface effectively on project teams.

High levels of integrity, honesty and maturity.

Additional Compensation Information:

Title based on candidate experience

Relocation Support:

This position is approved for $5000.00 relocation expense

Vacancy expired!

Subscribe Report job