Abbott QA/RC Specialist for Nordic & Baltic in Glostrup, Denmark
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
For our Quality team, we are looking for a
QA/RC SPECIALIST FOR NORDIC & BALTIC Based in Sweden or Denmark
As a QA/RC Specialist you will be proactively monitoring the QMS performance in line with corporate KPI’s, maintaining appropriate Quality records, implementing and monitoring compliance with procedures and will have responsibility in the event of field actions.
You will be supporting across all Abbott Medical Divisions the Nordic and Baltic countries, and wider North Europe region as required.
The position can be based at either the Abbott Medical office in Kista, Sweden or the office in Glostrop, Denmark, and will report to the Quality Assurance & Regulatory Compliance Manager, North Europe, based in the UK.
YOUR CORE RESPONSIBILITIES WILL BE:
Organizing, maintaining and keeping up-to-date a filing system for all Quality records, including all documents associated with Product Event reporting and Vigilance as agreed with the RC/QS Manager and in accordance with the requirements of relevant written procedures.
An advocate for the Quality System in the Nordics & Baltic
Encouraging staff to take ownership of the procedures that apply to their specific work area
Ensuring local procedures are up-to-date; relevant to current/best practice and that they meet the requirements of the Quality System.
Using initiative and persistence to assist the RC/QS Manager to encourage continuous improvement of procedures, processes and practices, providing routine training to improve compliance where necessary.
Maintaining a detailed knowledge/awareness of the Standard Operating Procedures and Local Instructions covered by the Quality System. Use this knowledge to pro-actively monitor compliance with these procedures, working with the RC/QS Manager to complete local assessments and identify/resolve issues.
Providing training on the Quality system for new and existing staff where needed.
Preparing for and follow-up on internal/external audits.
Coordinating and providing responses to routine requests for information on vigilance related issues, liaising with the manufacturing divisions as required.
Coordinating the implementation and follow-up of field actions, reporting progress and any issues to the RC/QS Manager
THE REQUIREMENTS FOR THIS ROLE ARE:
Educated to Degree Level
Knowledge of the local Medical Device regulation, relevant sections of the EU regulation, EU Medical Device Directives, ISO 13485 or significant experience working in another regulated industry e.g. Pharmaceuticals, Aviation
Swedish/ Danish and English language skills essential, ideally other Nordic languages as well; strong written and verbal communication skills
Ability to develop some technical understanding of the devices we sell
Basic knowledge and understanding of Cardiac physiology preferred
Excellent interpersonal skills, able to work independently as well as contributing to a team
Detail-oriented, excellent in priority setting and have strong analytical and diagnostic skills in problem solving
Willingness to travel up to 25% within EU
Are you flexible, a quick learner? Do you take responsibility, ownership and would you like to be the face of the Quality team in the Nordic & Baltic region?
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org