Principal Quality Assurance Professional – Combination Products

at  ALKAbell

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ou will as Principal QA Professional be part of Global Quality and join a team of skilled colleagues.
Your main task will be to provide support and be directly responsible for a range of quality assurance functions related to medical devices, and you will contribute to ensure that development and maintenance of Medical Device and Combination Products conforms to established regulation and internal ALK requirements. You will also demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

Your primary tasks will be:

• Quality and compliance support to Medical Device and Combination Products.
• Review and approve of component related documentation: drawings and quality control specifications for medical device and combination products.
• Review and approve of measurement and validation reports for component tools used for medical device and combination products.
• Review and approve of documentation related to Design Control for Medical Device and Combination products.
• Monitor quality and compliance performance of Global Device Development department.
• Provides on-site guidance in the preparation of procedures and working instructions.
• Assists in providing resolution to quality issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
• Helps support a permanent inspection readiness status.
• Provide QA support for regulatory filings and in relation to supplier management activities.
• Provide quality expertise, advice and/or assistance across the organisation as required.
• Perform external quality and vendor qualification audits, risk assessments and write audit reports, and follow up on observation close-outs.
• Provide quality support to technology transfer projects associated with devices.

BECOME A PART OF ALK

We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation.
Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.
Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

• Quality and compliance support to Medical Device and Combination Products.
• Review and approve of component related documentation: drawings and quality control specifications for medical device and combination products.
• Review and approve of measurement and validation reports for component tools used for medical device and combination products.
• Review and approve of documentation related to Design Control for Medical Device and Combination products.
• Monitor quality and compliance performance of Global Device Development department.
• Provides on-site guidance in the preparation of procedures and working instructions.
• Assists in providing resolution to quality issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
• Helps support a permanent inspection readiness status.
• Provide QA support for regulatory filings and in relation to supplier management activities.
• Provide quality expertise, advice and/or assistance across the organisation as required.
• Perform external quality and vendor qualification audits, risk assessments and write audit reports, and follow up on observation close-outs.
• Provide quality support to technology transfer projects associated with devices