Senior QA Specialist

Carl Zeiss Meditec, Inc. is the worldwide leader in ophthalmic diagnostic instrumentation. We design, manufacture, service and support products specifically designed to advance the standard of eye-care worldwide.

Protecting one of our most precious senses --sight, our employees contribute to the quality of life. We pride ourselves in fostering creative thinking and innovative ideas in a team-building environment. We reward success and cultivate open communication.

If you are passionate about making a difference in the lives of others and are interested in cultivating your talents in a challenging and rewarding environment, Carl Zeiss Meditec, Inc. may offer you the ideal career opportunity.

We currently have an exciting opportunity for a Senior QA Specialist to be responsible for implementing and maintaining system level processes and activities specific to products manufactured outside of our Dublin plant. In addition, the Senior QA Specialist may participate in Management Reviews, Material Review Board (MRB), quality planning, third party audits and support writing of standard operating procedures as needed.
* Ensure compliance with applicable state, federal, and international regulations and standards.
* Monitor and control the quality of product distribution.
* Manage complaint investigation activities specific to international product.
* Review and revise standard operating procedures related to areas of responsibility.
* Coordinate activities for product recalls and reportable events in the international market.
* Plan and conduct verification and validation of quality system software as needed.
* Establish goals, plans, and procedures related to areas of responsibility.
* Maintain and improve quality systems.
* Work in accordance with quality system procedures.
* Manage projects with minimal supervision.
This Senior QA Specialist will report to the Sr. Manager, Quality Systems.
REQUIREMENTS:
* BS degree in engineering, physics or equivalent field is preferred.
* Minimum of five years relevant work experience in quality assurance for medical devices with at least 2 years in a leadership role.
* Experience working with quality systems, including the design and implementation thereof, required.
* Knowledge of ISO 9001:2000, ISO13485:2003, and 21 CFR Part 820 quality systems is required.
* Understanding of statistical techniques such as normality analysis, confidence intervals and should be able to analyze and interpret data with high confidence, preferred.
* Able to manage multiple projects simultaneously.
* Excellent oral and written communication skills.
* Ability to adapt quickly to change and work in a rapidly changing environment.