Quality Specialist II

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

(Ottawa, ON)

Discover Impactful Work:

The Quality Specialist will work directly with customers and suppliers to quickly address quality related issues. You will be responsible for the daily execution of core quality functions/ processes under the supervision of the Quality Assurance Manager

A day in the Life:

• Participate in all aspects of the QA job function, e.g. processing of complaints, quarantines, change notifications, customer surveys, quality certificates, internal audits, generation of supplier and team metrics, etc
• Participate as the Admin for handling Recalls, Customer advisories, Field actions and complete compliance reporting to regulatory bodies.
• Collect and analyze quality data and distribute quality reports.
• Author Standard Operating Procedures, Work Instructions, Flow charts and support Quality document review other applicable departmental documents
• Support with Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are detailed, complete and timely.
• Participate in both internal and external audits of the Quality Management System
• Participate in continuous improvement projects through practical process improvement and tasks as assigned by the Quality Manager.

How will you get here:

Minimum Education

• Minimum Bachelor’s Degree in a scientific field, e.g. chemistry, biology, biotechnology, or mathematics

Experience

• Minimum three (3) years of applied experience in an ISO 9001, ISO 13485 and/or regulated environment.
• Two (2) years quality auditor experience preferred
• Experience with post market surveillance activities such as recalls, customer notification, field actions.
• Experience with CAPA, skilled investigation, root cause analysis and containment activities
• Experience in crafting and driving presentations.
• Experience interacting with customers, suppliers, and senior management.
• Experience using Quality Management Software, e.g Master Control, Smartsheet

Knowledge, Skills, Abilities

• Knowledge of Health Canada/FDA regulations preferred
• Excellent oral and written communication skills
• Excellent interpersonal skills
• Strong computer and data analytical skills, using Microsoft office tools.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!