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

Abbott; Ottawa; On-site; CAD 80,000 - 100,000; Full time

Job summary

A global healthcare leader in Ottawa is seeking an experienced Quality Compliance Engineer. The role involves implementing quality systems, ensuring compliance, and leading projects. Candidates should have a Bachelor’s degree and typically six years of experience in a regulated environment. The position offers opportunities for career development and a commitment to diversity in the workplace.

Benefits

Career development opportunities

Flexible work policies

Investment in employee development

Qualifications

• Typically 6 years of related experience in Quality Compliance Engineering or similar in a regulated environment.
• Experience in medical device diagnostics or pharmaceutical industries preferred.
• Strong communication, interpersonal, and professional relationship skills.
• Ability to prioritize, handle multiple tasks, influence, and lead without authority.

Responsibilities

• Implement and maintain an effective Quality System.
• Ensure compliance with applicable policies and procedures.
• Lead groups and projects to resolve complex issues.
• Collaborate with other Abbott sites and divisions as needed.

Skills

Quality Assurance

FDA Regulations

Data Collection

Food Safety

ISO 9001

Mobile Devices

Root Cause Analysis

Quality Systems

OSHA

Food Processing

Quality Management

cGMP

Education

Bachelor's degree in Science, Engineering, or a related field

Tools

MS Office

Mastercontrol CAPA

Job description

JOB DESCRIPTION: 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 your family, be your true self, and live a full life. You will have access to:

• Career development within 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 worldwide and named one of the most admired companies by Fortune.
• A company recognized as one of the best big companies to work for, as well as a top place for diversity, working mothers, female executives, and scientists.
• Flexible work policies that promote a healthy work-life balance.
• Investment in employee development through training and growth opportunities.
• An environment where every voice is heard and valued.

The Opportunity

This position is based in Ottawa, Ontario, within the Point of Care Diagnostics division. We empower smarter medical and economic decision-making to help transform health management at all life stages. Over 10 million tests are run daily on Abbott's diagnostic instruments, providing lab results for millions.

Our Point of Care portfolio covers infectious disease, cardiometabolic, informatics, and toxicology areas.

What You'll Do

• Implement and maintain an effective Quality System.
• Ensure compliance with applicable policies and procedures.
• Lead groups and projects to resolve complex issues; analyze problems, assess impact, and ensure compliance.
• Lead cross-functional quality system process improvements, including training, CAPA activities, equipment maintenance, product and process planning, audits, and validation.
• Collaborate with other Abbott sites and divisions as needed.
• Complete documentation timely and accurately.
• Understand and comply with EHS policies, procedures, and guidelines.
• Promote a safe and healthy workplace environment.
• Perform other duties as required.

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related field.
• Typically 6 years of related experience in Quality Compliance Engineering or similar in a regulated environment.
• Experience in medical device diagnostics or pharmaceutical industries preferred.
• Experience with regulatory agencies preferred.
• Strong communication, interpersonal, and professional relationship skills.
• Ability to prioritize, handle multiple tasks, influence, and lead without authority.
• Ability to work independently and cross-functionally on complex problems.
• Demonstrated initiative, problem-solving, and critical-thinking skills.
• Proficiency with databases and computer software, including MS Office and documentation control systems like Mastercontrol CAPA.
• Knowledge of U.S. and international quality system regulations (e.g., 21 CFR Part 11, ISO 13485).
• Understanding of statistics and quality management principles.

Follow your career aspirations with Abbott, a company committed to diversity and employee growth. Abbott is an Equal Opportunity Employer.

Connect with us on Facebook and Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is N/A. Pay ranges may vary by location.

JOB FAMILY: Operations Quality

DIVISION: APOC Point of Care

LOCATION: Canada > Ottawa: 185 Corkstown Road

Additional locations, work shift, travel, and surveillance details are not specified or not applicable.

Required Experience: Senior IC

Key Skills

Quality Assurance, FDA Regulations, Data Collection, Food Safety, ISO 9001, Mobile Devices, Root Cause Analysis, Quality Systems, OSHA, Food Processing, Quality Management, cGMP

Employment Type: Full-Time

Experience: Years

Vacancy: 1