Our Inchinnan site is experiencing further growth across our Operations and Support functions and as we continue to grow and expand the site capabilities, we require an experienced Quality Engineer to join our team.
You will establish and maintain appropriate Quality Systems consistent with ISO13485 and FDA 21CFR Part 820, assuring compliance to in-house and/or external specifications and standards. You will have the opportunity to actively lead data collection, trend analysis, investigation and improvements to processes, products and systems.
What will you do?
Work closely with Production, Technical and Engineering teams to resolve quality related issues arising from customer complaints/concerns and internal incidents. Responsible for the facilitation of investigations and resolution of related quality issues.
Work with technical support and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. Identify and implement opportunities for improvement across the operational facility.
Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
Participate on the Internal Quality Audit team.
Assure compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods.
Who we are looking for:
Bachelors/Masters degree in Chemistry, Biochemistry, Microbiology, Engineering or related discipline.
Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
Proven quality experience and demonstratable working knowledge of compliance, quality and scientific principles. You should be proficient in Six Sigma tools and methodology or equivalent Continuous Improvement Tools.
Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company.
Effective communication skills and the ability to collaborate with internal and external development team members.
What’s in it for you:
Contributory Pension Scheme
Private medical insurance
Free car parking
On site gym – subsidised
Generous Annual Incentive Plan
A variety of flexible benefits
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues 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 and Patheon
With Thermo Fisher Scientic, it’s not just a career. It’s a chance to realise your best – professionally and personally.