Staff Quality Engineer

Job Title

At Thermo Fisher Scientific, 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.

This role is based at our Burlington site, supporting our Lab Automation group. The facility is ISO 9001 certified. Our team designs, manufactures, and installs robotic solutions globally, accelerating drug discovery, research, and clinical testing for major pharmaceutical and biotechnology customers.

You will play a pivotal role in qualifying custom automated laboratory projects within a GxP environment, ensuring our products meet the highest quality standards. Additionally, you will collaborate with our internal team and vendors to drive continuous improvements in our products and processes. This involves analyzing non-conformance data to identify systemic issues and leading corrective action initiatives.

What You Will Contribute:

• Lead quality-related discussions with customers and the factory to ensure clarity and alignment on project specifications
• Develop and implement GxP validation plans in collaboration with customers and internal teams.
• Coordinate with internal teams to develop acceptance test plans, build IQOQ checklists and test scripts, and implement them as required
• Train and mentor staff on quality assurance practices and regulatory requirements
• Maintain a robust QMS through performing audits and inspections to identify areas for improvement and ensure adherence to quality protocols
• Initiate, track progress, and drive the resolution of complaints, CAPAs, deviations, non-conformances, and supplier corrective actions
• Champion Supplier qualification activities, quality system assessments, and process/facility audits. Maintains relationships with Suppliers to achieve quality objectives
• Engage in diverse quality initiatives to mitigate risks and drive excellence across the business

Education:

• University degree in Engineering, Quality Management, or related field.
• ASQ Quality Engineer certification (CQE), or equivalent an asset

Experience:

• Minimum 8 years' quality experience in Manufacturing or Life Science Environment
• 3 years' in a role directly collaborating with customers in a professional environment
• Exposure to GxP or ISO13485 requirements and standards is an asset

Knowledge, Skills, Abilities:

• Outstanding written and verbal communication skills to effectively articulate complex technical concepts and regulatory requirements to a diverse audience
• Strong organization, planning and time management skills
• Professional presence
• Understanding of the Qualification, validation processes, problem-solving tools and quality management system requirements
• Proficient with Microsoft Office Suite (Excel, Word, etc.)

Other Requirements:

• Valid Passport
• Ability to travel 5 - 10% of the time internationally without restrictions

At Thermo Fisher Scientific, each one of our 125,000 outstanding minds has a unique story to tell. Join us on our mission—enabling our customers to make the world healthier, cleaner, and safer.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.