Senior Manager Quality Assurance & Product Compliance (m/f/d)

at  Azenta

At Azenta Life Sciences, a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.
B Medical Systems, an Azenta Life Sciences company, was founded in 1979 when Electrolux partnered with the World Health Organization to create a solution for the safe storage and transport of vaccines around the world. Since that time, B Medical has become a global leader in vaccine cold chain. For over 35 years, we’ve been innovating and creating technologies that save lives across the globe.
In 2015, B Medical Systems was acquired by Navis, a private equity fund. Effective October 2022, a new chapter began and our company is a part of Azenta Inc., a leading worldwide provider of life sciences solutions.

HOW YOU’LL ADD VALUE

We are looking for a Senior Manager Quality Assurance & Product Compliance (m/f/d), who ensure that products and services meet internal, legal and customer requirements by planning, directing and coordinating quality assurance programs and formulating quality control policies to improve the organization’s efficiency and profitability. Take regulatory responsibilities related to product compliance, risk management and post-market activities of medical devices. As PRRC (Person Responsible for Regulatory Compliance) exercise the duties as required by the European Medical Device Regulation (EU) 2017/745 – MDR.

ABOUT US

Azenta Life Sciences is a global life sciences leader headquartered in Burlington, MA, with offices and operation sites around the world. We are the market leader in automated biospecimen management solutions and genomic services in areas such as drug development, clinical and novel cell therapies for the world’s leading pharmaceutical, biotech, academic and healthcare institutions. Our laboratory analysis, sample management and storage, informatics software and consumables services offer unparalleled capabilities and have the largest installed base managing over one billion samples worldwide.
For more information: https://careers.azenta.com/
B Medical Systems S.à.r.l.
an Azenta Life Sciences company
17, Op der Hei
L-9809 Hosingen, Luxembourg
Christina Knappe (Senior Recruiter Central Europe)
christina.knappe@azenta.com

• Contribute to the creation and implementation of the strategy and development in terms of Quality Assurance activities.
• Establish the company’s Quality Management System (QMS) compliance to ISO standards, applicable regulations, and all associated tasks around Quality Management
• Support and collaborate with different internal departments in relation to Operational Quality (Production Quality, Quality Control, Supplier Quality), including participation in Quality Circle, support and overview of the CAPA activities.
• Act as company’s representative for all activities related to product certification and the registration of products in and outside the European Union
• Carry out and/or support all risk management activities and conduct risk assessments of processes and tasks
• Ensure the conformity in terms of Safety Officer for Medical Devices
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
• According to Article 15 of the European Regulation (EU) 2017/745 for medical devices, T
• The PRRC (Person responsible for regulatory compliance) responsibilities are according to the article 15 of the European Regulation (EU) 2017/745 for medical devices