Quality Specialist II

Work Schedule

Standard (Mon-Fri)

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
• Support with Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are detailed, complete and timely.
• Facilitate CAPA/Risk Management Board Meetings
• Support with 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
• 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.

Keys to Success:

Education

• Bachelor’s Degree or equivalent experience in a technical/scientific field, e.g. chemistry, biology, or mathematics

Experience

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

Knowledge, Skills, Abilities

• Knowledge of Quality Management System
• Understanding of Health Canada regulations.
• Excellent oral and written communication skills
• Strong computer and data analytical skills, using Microsoft office tools.

Physical Requirements / Work Environment

Office- Settings

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation

The salary range estimated for this position based in Ontario is $56,400.00–$84,600.00.