Quality Specialist II

Posted 6 Days Ago
Be an Early Applicant
Ottawa, ON
1-3 Years Experience
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
The Quality Specialist II at Thermo Fisher Scientific will work directly with customers and suppliers to address quality-related issues, execute core quality functions, participate in audits, and contribute to continuous improvement projects. Minimum education required is a Bachelor's Degree in a scientific field. The position requires at least three years of applied experience in an ISO 9001, ISO 13485 regulated environment, and strong knowledge of Health Canada/FDA regulations. Excellent communication, interpersonal, and computer skills are essential.
Summary Generated by Built In

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!

Top Skills

Microsoft Office Tools
The Company
HQ: Waltham, MA
100,000 Employees
Hybrid Workplace

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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