Sr. Quality Release Technician

Job Title: Senior Quality Release Technician

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
We are looking for an experienced QA Professional to join us in this newly created position that will be part of Release Team based at our production site in Roskilde, Denmark. The team is a part of the Operation Quality Department which ensure the release of consumables for laboratories and large-scale production sites.

How will you make an impact?
As our new Senior Quality Release Technician, you will be responsible for, and will ensure the required review and control of conformance before final release and ensure compliance with MDR requirements on conformity of the device is in accordance with the Quality Management System before release.

You will cover the daily responsibility for QA review and release of medical device lots and Raw material including review of required Certificates on all incoming components.

You will be responsible for the daily coordination and oversight of Batch Release / Device History Records. You will also be responsible for the inspection of helping materials and components and support the daily collaboration between QA Release and process control department as well as other QA and production stakeholders.

What will you do?
• Ensure incoming inspection is registered according to requirements in the QMS, Lot number in QMS as well as registration of results from sampling to ensure full traceability at lot release
• Ensure that visual inspection and testing of samples is conducted according to documentation and specifications
• Review of relevant batch documentation, final release and archiving
• Initiation and conduction of Non-Conforming Material failure reports/Trackwise CAPA cases in relation to review and release
• Support validation documentation, Change Control and document update
• Keep updated on all documentation covering DHR review and release
• Participate in relevant improvement activities that can impact the Review & release process e.g. Complaint handling, CAPA’s and Kaizen
• Participate in on site audits covering the release activity
• Support and back-up for the process control
• Release of manufactured products according to effective documentation and specifications.
• Registration of results in respective electronic systems.
• Keep order in the areas of where the release activities and archive for the release specific areas are ongoing

How will you get here?
Experience
• 2-5 years’ experience with Medical Device review and final release activities
• Experience with current GMP expectations within the Medical Device industry and ISO landscapes as e.g. 13485, 14971
• Experience with DMR, DHR, Quality Control activities and documentation

Knowledge, Skills, Abilities
• Knowledge of visual inspection and functional testing
• Fluent in Danish and English
• Good IT- and communication skills
• Ability to structure and prioritize work tasks up against expected deadlines and decision making where required
• Contribute to good relations and well-being in the department
• Flexibility and ready for change within tasks/processes and job responsibility
• Contribute with improvement needs and ideas where possible

At Thermo Fisher Scientific, each one of our 70,000 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.

Apply today!

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.