Quality Specialist

Job Description Job Description About Us:

How many companies can say they have been in business for over 178 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it with cutting edge 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: Dublin, CA What’s the role?

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

Support internal and external Quality System audits.

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. Job Requirements

Do you qualify?

The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.

Two plus (2+) years of experience working in Quality Assurance in a GMP regulated industry and good working knowledge of FDA medical device regulations

Ability to deal with diverse groups such as customers, health care professionals, vendors, and regulatory auditors with a high level of professionalism and under adverse or stressful circumstances

Effective writing and communication skills