Senior Specialist, Quality – Abbott Point of Care (Ottawa)

About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You Will Have Access To

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• We offer flexible work policies that allow a healthy balance between personal and professional life
• We invest in the development of our employees through training and growth opportunities
• We foster an environment where every voice is heard and valued

The Opportunity This position works out of our Ottawa, Ontario location in the Point of Care, Diagnostics division. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics and toxicology. What You’ll Do

• Responsible for implementing and maintaining an effective Quality System.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• independently lead groups and projects to resolve complex issues; analyze complex problems and identify their impact; establish probabilities; draw conclusions reflecting broad business needs; ensure compliance;
• Cross-functionally lead Quality System process improvements which may include training; corrective action and preventative action (CAPA) activities, equipment maintenance, product and process planning, quality audits, and validation;
• Work may require collaboration with other APOC sites and/or other Abbott divisions;
• Responsible for completing documentation in a timely manner and in accordance with business standards;
• Understand and comply with applicable EHS policies, procedures and guidelines;
• Safeguard the environment and facilitate a safe and healthy workplace culture.
• Other miscellaneous duties as may be required.

Required Qualifications

• Bachelor’s degree (Science, Engineering or a closely related discipline)
• Typically requires 6+ years of related experience in (such as Quality, Compliance, Engineering) within a regulated environment.
• Experience in the Medical device, diagnostics or pharmaceutical industries is preferred.
• Previous experience with regulatory agencies is preferred
• Ability to clearly, concisely and accurately convey communications;
• Ability to form and develop interpersonal, professional relationships; displays socially and professionally appropriate behavior;
• 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 or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;
• Demonstrated initiative and problem-solving skills; critical-thinking skills;
• Ability and aptitude to use various types of databases and other computer software;
• Strong organizational and project management skills
• Knowledge of applicable U.S. and non-U.S. Quality System Requirements and other relevant regulations for medical devices;
• Knowledge of software regulations and compliance (21 CFR Part 11);
• 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.
• Knowledge and understanding of statistics
• Job requires daily use of basic computer software like MS Office (Word, Excel and PowerPoint) as well as Lotus Notes
• Job requires knowledge of Documentation control database (e.g. Mastercontrol, CAPA)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.