Abbott Senior Quality Assurance Engineer, Abbott Point of Care (Ottawa) in Ottawa, Ontario
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 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-centred 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 metre, state-of-the-art manufacturing facility, Abbott Pointe, is located in Ottawa, Ontario, Canada.
Status : Regular, Full Time
We are currently seeking a Senior Engineer for our Ottawa test cartridge manufacturing facility. As a member of QA Operations team, the main responsibility in this role will be to assist in the maintenance and implementation of the Quality Management System that meets the needs of the corporation and that ensures compliance with all applicable regulatory and Abbott corporate requirements.
The role will focus on leading and understanding validation and verification requirements for medical device manufacturing: Facilities, Utilities and Equipment, Process, Product, Test Method etc. This role will provide the leading voice from the QA organization on validation requirements (Regulatory and Abbott corporate) as well as guide the actions of the Engineering and Operations staff when writing and performing validation/verification work. This role will be responsible for the maintenance and improvement of the APOC validation system within the QA Operations team, as well as other regular QA Operations duties and responsibilities.
Monitors and reports to upper management on projects (project planning issues, compliance activities in including audit preparation, verification and validation, along with verification and validation status.
Participates in continuous improvement initiatives
Builds and maintains successful cross functional relationships with internal departments such as R&D, Engineering, Manufacturing, Operations, Quality and Regulatory Affairs.
Serve as the QA representative on on-market development/maintenance teams.
Provide support to Validation activities.
Understand and comply with applicable EHS policies, procedures, rules and regulations.
Other tasks and duties as assigned.
Required Skills & Abilities:
Three to six years working experience in a related field.
Proven technical, creative, teamwork and implementation skills to contribute to process reliability and product manufacturability/performance are required.
ISO 13485 and the FDAs Good Manufacturing Practices.
Experience writing/reviewing &/or approving validations of Facilities/Utilities/Equipment/Products/Processes
Strong organizational, written and verbal communication skills are mandatory.
Excellent problem solving and analytical skills.
Ability to quickly gain knowledge, understanding or skills and willingness to learn.
Knowledge of Lean Six Sigma concepts is an asset.
Proficiency with MS Office is required.
Required Education and Experience:
- 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org