Engineer, Intermediate (Quality Operations), Abbott Point of Care (Ottawa) Job in Ottawa, ON at Abbott Laboratories
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.
We are seeking an energetic and driven Intermediate Engineer who will play a key role on the quality operations team supporting validation and change control for high volume manufacturing activities. The successful candidate must have strong attention to detail, excellent communication skills and strong organization skills and ability to follow the quality management system and ensure that protocols and verification studies meet the intended requirements of the quality management system.
Review, and approve risk assessments for instruments, equipment, processes, and products.
Evaluate change control packages to ensure that equipment, products, processes, and facilities remain in qualified, validated state, including definition of appropriate requirements in change control documents, and tracking to completion the identified actions.
Work with the technical team to identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and document the impact upon qualification or validation as applicable and recommend appropriate corrective/preventive actions.
Plan and conduct work requiring judgment in independent evaluation, selection, and substantial adaptation/modification of standard techniques, procedures, and criteria.
Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.
Required Education and Experience
Typically requires 1-3 + years of related experience (such as Quality, Compliance, Engineering) within a regulated environment.
Experience with various quality system processes
Experience in the Medical device, diagnostics or pharmaceutical industries is preferred.
Previous experience with regulatory agencies is preferred.
Bachelor’s Degree in STEM, or equivalent;
Knowledge of ISO 13485; Knowledge of quality management techniques and the application and principles of quality engineering, strong knowledge and application of concepts, practices and procedures.
Demonstrated initiative and problem-solving skills; critical thinking skills;
Ability to clearly, concisely and accurately convey communications;
Ability to prioritize and handle multiple tasks;
Ability to influence and lead without direct authority;
Ability to work independently and in groups; ability to work cross-functionally;
Ability to collaborate effectively with multidisciplinary team members and also to work independently;
Propensity for continuous learning and experimentation.
Experience in the development, validation, or quality review of high volume automation is an asset.
Experience with statistical software an asset.
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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About the Company
Company: Abbott Laboratories
Company Location: Ottawa, ON