Company: Abbott Point of Care
Address: 185 Corkstown Road, Ottawa, ON

POSITION: Sr. Product QA Specialist

Abbott Point of Care is a market leader in point of care testing, based in Ottawa, Ontario and Princeton, New Jersey. The i-STAT System offers a diverse menu of blood gas, chemistry, coagulation and cardiac marker assays, which facilitates improved patient care by ease of use and rapid time to accurate results. With annual growth in sales above 20%, Abbott Point of Care is a dynamic and exciting work environment.

Primary Function / Primary Goals / Objectives / Outputs:

• Responsible for monitoring the field quality of Abbott Point of Care products through Technical Support contacts, complaint trending, risk evaluations and corrective and preventive action activity. Requires interfacing with others within company, and preparing reports using Microsoft programs such as Excel and Access
• Support multiple investigations, risk evaluations, customer communications and field actions. Review output of database using standard reports to determine aging cycle of incidents and document discussions and meeting outputs on specific incidents.
• Organization,Assignment and follow up of investigations to investigators of cartridge investigtions
• Working knowledge of Federal Regulations (not limited to 21 CFR 806 , 21 CFR 820, and Medical Device Reporting Guidelines) and understanding the consequences of product issues on product performance, customer acceptance, customer risk, and compliance.
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Primary / Major Responsibilities:

• Implements and maintains the effectiveness of the quality system.
• Uses tracking and trending techniques on the Product Complaint System.
• Analyzes quality reports generated by the QA Specialist and detects and specifies the source of trends and determines the appropriate course of action to resolve identified issues.
• Uses authority to remove barriers that block goal attainment; influences others to support the identified course of action; takes personal responsibility to resolve issues.
• Works effectively and cooperatively with others; establishes and maintains good working relations to ensure accomplishment of goals.


Education:

A bachelor’s degree in an engineering or scientific discipline or equivalent experience, with 4-6 years relevant experiences in a clinical laboratory, diagnostic quality or technical area.



Knowledge:

Knowledge of regulations and standards affecting IVDs and Biologics. Knowledge and prior experience in ISO standards and guidance documents and the FDA Quality Systems regulations is desired. Knowledge of complaint handling and field requirements required. Prior experience in the medical device and/or in-vitro diagnostic industry required. Prior experience as a Quality Engineer or Quality Associate helpful.

Accountability / Scope/ Impact:

• Failure to meet these requirements could result in user injury, FDA warning letter, product recall, or other FDA imposed actions.
• Collect data from multiple sources on Quality Metrics and prepare summaries for corporate distribution.
• Participate in process improvement or product development teams.
• Receives general direction; exercises considerable discretion as to work detail.
Defines overall project goals and time-frame for completion.