QA Specialist, Sr

About Us:

How many companies can say they've been in business for over 177 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements.

ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change.

We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology.

We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region: This position is located in Dublin, CA

What's the role?

Under direct supervision of the Manager of Complaint Handling, the Senior QA Specialist is responsible for evaluating, following up to gather additional information, and escalating Critical Incidents and Sustaining Issues (escalated complaints) to the Complaint Handling Unit of the Manufacturing site.

The Senior QA Specialist directly interfaces with health care professionals and internal employees at multiple levels within the organization to ensure complaint handling and regulatory reporting obligations of the company are met.

Sound Interesting?

Here's what you'll do:


* Responsible for timely evaluation, preliminary investigation, and submission of complaints to the Complaint Handling Unit of the Manufacturing Site.


* Conduct interviews and follow up with customers/health care providers, sales reps, and other internal employees to gather information for complaint reporting and investigations.


* Support the complaint trending/monitoring process.


* Create and submit Medical Device Reports (MDR) to the FDA.


* Support Field Corrective Action activities (Recall, Field Safety Corrective Action), including regulatory reporting obligations.


* Develop and present complaint handling training for new employees.


* Support internal and external Quality System audits through contribution of technical knowledge of subject matter and facilitation of quality related documentation and records.


* Support in the development and maintenance of the Company's Standard Operating Procedures to ensure regulatory compliance.


* Participate in continuous improvement activities, and maintenance of metrics, and other performance indicators.


* Special projects as required supporting departmental goals.

Do you qualify?


* BS/BA degree Business or Technical field.

Equivalent education or experience may be considered.


* Minimum five (5) years of experience working in Quality Assurance in a GMP regulated industry and good working knowledge of FDA device regulations (e.g.

21CFR820, 21CFR803, 21CFR806, etc.).


* Experience in Complaint Handling.


* Experience in Field Corrective Actions (Recall, Field Safety Corre...