As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 17 billion in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
Quality Systems Engineer
Are you passionate about making a difference? Do you want to be a part of a company known to be a fast paced global leader in serving science? Do you have a strong quality background, preferably from a similar role with Medical Devices then this could be the right opportunity for you.
We are currently looking for a new colleague with real integrity and can-do-attitude to join our site team in Roskilde. You thrive on working in a deadline driven and dynamic environment, and you take pride in delivering good results. You are structured by nature, and dedicated about working with quality – always with a focus on how to create value for the business. Teamwork and professionalism is essential to the way we work, and we need your good spirit and commitment to meet our objectives.
Reporting to the Quality Manager you will be a key member of the Laboratory Products Division quality team for the site located in Roskilde. You will be focusing on updating and developing the Quality Management System – QMS, system, as well as closing non-conformances. The role will provide guidance and decision making in all activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards, and as an important first task, you will be the project lead on upgrading our QMS systems to the new ISO standards ISO 9001:2015, and ISO 13485:2016.
- Update and continuously improve the Quality Management System for compliance to current standards and regulations and customer requirements
- Facilitate improvements of the Quality Management System and provide training in the QMS and GMP
- Ensure an efficient CAPA-system; CAPAs shall be handled and verified in a timely manner
- Host and follow up on external audits (Notified Body, Authorities, Customer Audits)
- Act as Project manager/representative on implementation of new Quality IT system
- Represent the Roskilde site (Laboratory Products Division) in QMS improvement projects
- Degree qualified in engineering or a related field from relevant discipline, or the equivalent knowledge and experience from the Life Science industry
- 3-5 years demonstrable competence gained through successful experience from similar role, preferably with Medical Devices
- Working experience with ISO 13485 & ISO 9001. Understanding of MDD, IVDD , FDA 21 CFR part 820 is desirable but not a requirement
- Solid experience as facilitator and influencer capable of translating and communicating complex information
- Strong critical thinking skills with attention to detail without losing the greater picture
- Organized, structured and decisive with the ability and willingness to work in ambiguous situations
- Good and strong communication skills in Danish and English adept with communication at all levels as well as with customers / stakeholders in a professional and effective manner
- Self-motivated and driven with excellent leadership and teamwork skills
What we can offer:
- A career in an international company with a global impact
- Access to the brightest minds within your field
- Development through continuous learning and developing skills and abilities
- Cooperation with colleagues and teams across business areas
- Opportunity to make a difference
We look forward to receiving your application, including a cover letter and CV in English. Please apply via http://jobs.thermofisher.com/. Reference: 43284BR.
Application deadline is: 14th Feb. 2017
If you have questions about Thermo Fisher Scientific and/or the position - please contact Heidi Lund-Nielsen, Sr. Recruiter Nordics via email Heidi.email@example.com.