Job Title: Senior Quality Engineer
 

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. For more information, please visit www.thermofisher.com.

 

Overview

The QMS team of 4 people is a part of the QA department, based in Roskilde. Together with Technical Quality and Operational Quality the QMS team support the organization in quality related issues according to relevant standards and requirements and maintain quality processes within the responsibility of the QA department.

 

How will you make an impact?

In this role as a Senior Quality Engineer you’ll be able to put your own experience forward and use your initiative to develop new and improve existing processes. You will be overall responsible for supplier quality system as well as process owner of the Change process. Reporting to the QMS Manager you will provide continuous quality support to the organization within improvement projects, Changes, Complains, CAPAs, NC as well as create an environment to encourage and promote adherence to Quality Assurance policies and requirements.

 

What will you do?

• Lead, manage and implement standard work for quality activities
• Lead, manage and implement standard work for supplier quality activities in cooperation with sourcing and purchasing
• Approval, contracting and monitoring of quality performance of suppliers within quality incl. drive development of clear specifications and NC etc.
• Process owner of Change Order process
• Provide general quality support to the organization (suppliers, complaints, observations, CAPA, NC, audit etc.)
• Optimize and implement processes and document it in Quality Management System
• Facilitate improvements within Quality and provide training in QMS and GMP to the site
• Participate in and ensure follow up on internal audits as well as external audits (Internal, Suppliers, Notified Body, Authorities, Customer Audits,)
• Promote continuous improvement within the department and provide support to other departments in improvement activities
• Consistently promote high standards
• Drive quality strategical projects in the organization

How will you get here?

• Preferable; education as bachelor’s degree in related field, or the equivalence of education and experience combined
• Knowledge of Medical Device regulation
• 10 years of experience within QA processes
• Used to work in a GMP environment within the Medical Device industry (ISO 9001 & ISO 13485, and the European Medical Device and IVD legislation)
• Knowledge of FDA 21 CFR Part 820
• Ability to understand and interpret specification and use as a basis for routine decision making and actions
• Operate with accuracy and attention to detail, strong analytic and problem solving skills
• Good IT and document writing skills in Danish and English

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.