Job Title Director, Quality Assurance (Division, Ottawa) 
Job Family Quality Assurance
Job Category Full-Time
Job Classification Established
Division Abbott Point-of-Care
Shift. Monday to Friday
Job Description PURPOSE OF JOB

Reporting to the APOC Director, of Quality Assurance Regulatory Affairs and Validation with dotted
line reporting to the APOC Ottawa, Ontario Canada Plant Director, the Director of Quality Assurance will
provide strategic leadership through subordinate managers to the overall quality assurance management function including Quality Operations /Validation and Calibration; QA Test Engineering including, CAPA Projects, QA Change
Control and Documentation, and Statistical Consulting. In
addition, the position has indirect oversight of Incoming Quality Assurance and Internal Audits.

The Director, Quality Assurance will be responsible for alignment of APOC, Ottawa Manufacturing Excellence with global corporate standards and maintain link with Abbott Quality and Regulatory (AQR) processes and procedures. Oversee compliance with all regulatory requirements including FDA and ISO 13485 and take appropriate action
whenever required. To direct, manage and coordinate through professional staff development, implementation and maintenance of quality assurance systems.


ESSENTIAL DUTIES AND
RESPONSIBILITIES

• Bring managerial and strategic expertise in all matters pertaining to the quality systems. Define and implement quality objectives and strategy for medium and long-term
goals. Provide a strategic focus on emerging regulations and their potential impact on Abbott.
• Demonstrate the ability to achieve the difficult balance of
involvement and objectivity, perform risk analysis, and
prioritize key issues. Spearhead development and implementation of effective quality data collection
and information reporting systems.
• Serve as a resource/consultant for other departments and the Ottawa Senior Leadership Team regarding matters related to compliance with all applicable domestic and international medical device regulations.
• Ensures that the quality system requirements are effectively established and maintained.
• Ensures compliance with quality standards for all the activities on site (e.g., ISO, QSR), leads the staff in the design, development, implementation and maintenance of
company quality policies, systems, procedures, practices and metrics within the limits of corporate policy, e.g., collective and preventive action system
• Lead and provide support during regulatory agency inspections (FDA/Notifying Body/State/Corporate) and related preparation activities.
• Maintains external contacts with independent auditors and government agencies dealing with quality assurance.
• Oversees development and implementation of standards,
methods and procedures for inspecting, testing and evaluating for precision, accuracy and reliability of company products.
• Assures reliable, high quality product design and manufacture through identification of training needs and provision of training for all employees.
• Develops and manages quality assurance operating plans, budgets, procedures, equipment maintenance and training programs to ensure production operation support.
• Motivates employees through interpersonal interactions on a regular basis, mentoring, fostering creativity and innovation, empowerment, providing opportunity to learn, positive reinforcement, goal setting, sharing relevant
engineering and company information and providing ongoing positive feedback on accomplishments and immediate action to address shortfalls.
• Keeps up to date with the latest technical developments in the related area, and uses creativity and innovation in solving issues pertaining to the quality assurance.
• Performs other job-related duties as necessary.
Skills/Experience Requirements • Must have Supervisory Experience
• 10-15 years relevant experience in quality assurance preferably in a manufacturing environment.
• Must be well versed in FDA Regulations and ISO 13485
• Understanding of statistics and manufacturing processes, good expertise in all areas of accountability.
• Analytical and problem solving skills, creativity and innovation, coordinating and planning skills, leadership skills, ability to work under pressure in fast pace and multitask environment, excellent oral and written communication
skills, very good interpersonal skills to be able to deal with
people on all organizational levels, propensity to continuous
learning and experimenting.
Education Requirements • B.Eng. or B.Sc. in an appropriate technical field.
Country Canada
State/Province/Region Ontario
Site Location Abbott Pointe,Ottawa

Apply online at  http://www.abbottpointofcare.com/istat/