Senior Specialist Quality Assurance

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.

We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Sr. SQA will be responsible for training, oversight and measuring performance of complaint investigators and receiving clerks who investigate product returned by ADC customers in the Complaints Investigation Lab.

You will be expected to understand all aspects of the complaints investigations processes, manage resources to meet division goals for timeliness of complaint investigations and identify opportunities for improvement and / or better efficiencies in our investigation processes.

You will also be responsible for monitoring the quality of the complaints investigations that are performed.

What You’ll Work On

• Leads complaint investigation activities with regard to blood glucose meters. Ensures that complaints investigations are done according to procedures in a timely manner.
• Monitors people and processes with an eye towards improving the efficiency of the investigations that are performed. Also responsible for identifying any trends in product complaints that are found during investigations.
• Responsible for tracking all returned product, calibration and proper validation of all test equipment within the lab.
• Assists Lab Supervisor in performance evaluations as well as administrative duties.
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

Required Qualifications

• Bachelors degree or equivalent experience is required. Equivalent experience is defined as a minimum of 2 - 4 years work experience.
• Previous experience with complaints investigations in a regulated environment and knowledge of the FDA / QSR regulation and ISO 13485 standard is required.
• An understanding of ADC (Abbott Diabetes Care) product is ideal.
• Must be able to effectively lead a large staff of non-exempt employees including full-time and contract workers.
• Excellent communications skills are required as there may be interaction with other functions in ADC such as Customer Support, R&D, and Manufacturing.
• Must also be able to act autonomously and make decisions regarding the need to pursue further investigation vs. bring closure to an investigation.
• Complaints investigations are a primary focus of corporate and FDA audits. Investigations that are not conducted or documented properly could lead to an observation for ADC.
30+ days ago