Abbott Principal Engineer, Quality Software Validation, 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 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 metre, state-of-the-art manufacturing facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.
Status: Regular, Full Time
The position includes management of personnel and activities within the quality operations and manufacturing environment. Completes professional level engineering and management assignments related to software validation, data integrity and application of 21CFR part 11 requirements. Leads and participates in projects involving design, fabrication, validation, calibration and test of complex instrument subassemblies, systems or processes.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Implements and maintains effective quality system by supporting compliance activities.
Manages activities, tasks and priorities of Quality Engineering and Manufacturing staff, including production line support, change control data reviews and investigation and resolution of quality issues.
Manages internal metric reports to meet division requirements.
Identify and implement process improvements while maintaining compliance to quality regulations.
Responsible for non-product software validation requirements, maintenance of the data integrity, implementation and maintenance of system requirements for 21CFR part 11 Electronic Records; Electronic Signatures
Ensure EHS goals are established and achieved. Promote adherence to EHS policies, procedures, rules and regulations.
Other miscellaneous duties as may be required.
Ability to establish strategic direction and lead change.
Demonstrates the appropriate level of leadership experience to lead cross functional teams.
Advanced written and verbal communication skills.
Ability to confront and resolve conflict and lead efforts to resolve critical situations.
Interacts frequently with division management with executive responsibility and requires high levels of competence, confidence and credibility.
Strong customer interface skills.
Required Skills & Abilities:
Advanced technical understanding of Quality Systems/Policies/Procedures and medical devices or pharmaceutical products.
Advanced understanding of data integrity requirements for medical devices, including application of 21CFR part 11 requirements
Previous experience interacting with regulatory bodies
Previous experience with operations related quality system requirements.
Ability to evaluate complex processes.
Demonstrated good judgment and sound decisions. Required Education and Experience:
Bachelor's degree or equivalent experience required.
Typically requires a minimum of 6 – 10 years of medical device or pharmaceutical industry 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.
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Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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