Quality Engineer, Intermediate (QR/CAPA), Abbott Point of Care (Ottawa)

Job description

     

JOB DESCRIPTION:

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance.  We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square meter, state-of-the-art manufacturing facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.

Status: Full-Time/Permanent

Job Description: 

The purpose of this role is to support implementation of the non-conformance and CAPA processes for the APOC division.

This role will help train users on the Quality Record (non-conformance)/ Corrective and Preventive Action (CAPA) process, ABTRAQ (trackwise quality) system and ensure that the requirements of the process are clearly understood and followed in the organization.

This role will review non-conformances and CAPA to help determine root cause and corrective action and assist users to follow the processes to achieve excellent QR documentation.

This role will perform trending of key quality system data in order to determine any trends of data for the division to assist management in key decision making.

Responsibilities:

•  This position will have a positive impact on our overall operation and help determine root cause and corrective actions for key business and quality issues!

•  Participate and assist individuals or cross functional teams to complete non-conformance (NC) or corrective and preventive (CAPA) investigation documentation to meet APOC standards and quality & regulatory requirements.

•  Write, edit or approve non-conformance (NC) or corrective and preventive action (CAPA) investigation documentation for complex product or process (system) issues.

•  Guide and coach quality decision making investigations and CAPA’s.

•  Communicate technical and quality requirements pertaining to issues, root causes and corrective actions to your team, other leaders and others in the organization.

•  Deliver high quality documentation and project plans on time.

•  Track and trend CAPA metric data and create presentations for management reviews.

•  Conduct CAPA process and other required training for new Abtraq (Abbott TrackWise for Quality) users.

•  Other tasks and duties as may be assigned.

Required Experience and Education:

•  1– 3 years’ experience working in a GMP regulated or another regulated environment.

•  Problem solving and critical thinking skills in order to be able to analyze data, critical thinking and ability to draw conclusions from data.

•  Process based thinking and ability to analyze potential gaps in products or processes to determine root cause and corrective action.

•  Excellent writing skills and ability to bring complex information together in an organized and clear way.

•  Advanced technical writing skills and ability to bring complex information together in an organized and clear way.

•  Detail oriented with the ability to also make more broad connections with information and details.

•  Experience with the requirements for cGMP medical devices, pharmaceutical and/or with ISO13485:2016 environment is considered an asset. 

•  An Undergraduate University Degree in Engineering, Science, or related discipline preferred, or equivalent experience.

Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.

Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.  We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.

Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.

Join Our Talent Community to learn about upcoming job opportunities or connect with us at Abbott Canada , on LinkedIN , on Facebook and on Twitter @AbbottNews and @Abbott Global.

     

JOB FAMILY:

Engineering

     

DIVISION:

APOC Point of Care

        

LOCATION:

Canada > Ottawa : 185 Corkstown Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

M-F (Canada)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)