Quality and Compliance Specialist

Work Schedule

Environmental Conditions

Job Description

Position Summary:

Working closely with the Senior Quality Manager, the IES (Instrument & Enterprise Services) EMEA Quality Team, the global quality organisation, and regional management teams, the Quality and Compliance Specialist is responsible for driving quality across the commercial sites in Denmark, Sweden, the UK, the Netherlands, and Belgium.

This position ensures that the services quality needs of our customers are met and supports the continuous improvement of the quality assurance programme in alignment with evolving regulatory standards and market expectations.

This key role also undertakes developing and maintaining the data infrastructure for the IES EMEA Quality Team — managing SharePoint sites, workflows, and reporting tools — as well as managing document control.

This position is offered on a remote working basis, but it does require occasional presence on site in Allerød, as well as regular international travel within North EMEA.

Key Responsibilities:

• Develop and maintain required certifications/accreditations for IES sites in scope (ISO 9001:2015), ensuring alignment with EMEA, European, and global quality programmes
• Lead and support quality activities, including audits, management reviews, training, supplier oversight, nonconformities, complaints, deviations, CAPAs, quality events, and general compliance
• Support quality management needs for IES Enterprise Services in the countries in scope, as needed, while assisting local quality administrators and coordinating site-level quality reporting
• Communicate and coordinate quality-related activities with local management teams, employees, suppliers, and customers
• Support and implement quality and process continuous improvement initiatives, as well as quality and compliance improvement projects within designated countries, as needed
• Create and maintain documentation and quality tools on SharePoint
• Monitor training statuses, systems, QMS elements, and service agreements with vendors/suppliers
• Undertake additional duties as assigned by line manager.

Minimum Requirements/Qualifications:

• Bachelor’s degree level or equivalent experience (e.g. in Engineering, Quality, other relevant)
• Fluency in English, with additional proficiency in German preferred, and familiarity with Scandinavian culture
• Knowledge and understanding of EU or USA GMP and GLP regulations plus IQ, OQ, PQ (minimum 3 years' proven experience)
• Confirmed experience with quality management systems. Trained as internal auditor or having extensive experience of auditing
• Strong commercial competence and customer-centric approach, with great interpersonal skills and the ability to work independently
• Willingness to travel internationally (up to 40-50%) and to occasionally work from our Allerød offices (e.g. in connection with audits)
• Extended knowledge in Microsoft Office applications, including SharePoint and Ms Teams
• Experience/knowledge of ISO9001, ISO14001 quality standards. Additional knowledge of ISO 13485 would be an advantage.

What We Offer

• Remote working with the option to work from the office occasionally
• An international team of highly supportive colleagues
• Varied work, with excellent development opportunities