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.
We are currently seeking a Senior Quality Engineer for our Ottawa manufacturing facility QA Operations team. This role is responsible to assist in the maintenance and implementation of the Quality Management System to meet the needs of the corporation and to ensure compliance with all applicable regulatory and Abbott corporate requirements. This role will be heavily focused on software validation, ensuring that software Quality Assurance computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This role requires a strong knowledge of medical device quality system requirements (FDA, ISO etc.) as well as a propensity and understanding of software/mechanical/chemical/biomedical engineering, as used in a medical device manufacturing environment.
- Apply advanced scientific knowledge, engineering knowledge, mathematics and ingenuity to complete complex assignments with little or no supervision.
- Responsible for implementing and maintaining effectiveness of Quality System.
- Understand the business needs of the company and have a thorough understanding of customer and clinical needs as they relate to projects.
- Lead and/or participate on cross-functional teams to support organizational goals.
- Monitor and report 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.
- Build and maintain successful cross functional relationships with internal departments such as IT, R&D, Engineering, Manufacturing, Operations, Quality and Regulatory Affairs.
- Serve as the QA representative on on-market development/maintenance teams.
- Provide Quality support to internal engineering and manufacturing teams, with focus on, but not limited to, software quality assurance.
- Understand and comply with applicable EHS policies, procedures, rules and regulations.
- Serve as a subject matter expert (SME) or independent technical expert (ITE) on a project’s technical matters; may interface with senior management, external firms or agencies.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Review pre-defined deliverables/activities as identified in project plans or equivalent plans for accuracy, clarity, consistency, completeness and compliance with corporate and regulatory agency quality system requirements.
- Review and approve various documentation, including software (and other) System Specifications/Requirements documents, Verification/Validation Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Reports.
- Develop and maintain procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System.
- May Develop and maintain Validation Master Plan(s).
- Other miscellaneous duties and responsibilities as may be required.
Required Education and Experience:
- Minimum 3-6 years in a Quality Engineering or similar role is required.
- Bachelor’s Degree (Science, Engineering or equivalent) required.
- Knowledge and experience with general medical device Quality System regulations (ISO 13485, FDA CFR 820 etc.) required.
- Strong working knowledge of medical device software validation/verificationrequirements/regulations/industry practice required.
- Experience writing/reviewing &/or approving validations of medical device software/Facilities/Utilities/Equipment/Products/Processes is desirable.
- ASQ (CQE/CQA etc.) or other certification is desirable.
- Risk Management knowledge and experience.
- Experience or exposure to a manufacturing environment is an asset.
- Ability to work independently and in groups, ability to work cross-functionally.
- Demonstrated initiative and problem-solving skills; critical thinking skills.
- Ability or aptitude to use various types of databases and other computer software.
- Ability to prioritize and multi-task.
- Strong organizational and project management skills.
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Ability or aptitude to provide & review/approve solutions and contingency plans through the comprehensive review of alternatives.
- Ability to quickly gain knowledge, understanding or skills and willingness to learn.
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.
APOC Point of Care
Canada > Ottawa : 185 Corkstown Road
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)