Quality Assurance Manager

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.

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.

BMedical 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.

Since 2024 also our Barkey product portfolio medical heating technology has been located in Luxembourg.

Our international Quality team is looking for a **Quality Assurance Manager (M/F/d) medical heating technology **onsite in Hosingen, Luxembourg.

**Travel activity**: 20% travel if on site, 50% if remote

**How you'll add value**

**What you'll do**
- Quality Management Systems: Develop, implement, and maintain global quality management systems (QMS) in compliance with ISO 13485, EU MDR, and US FDA regulations (QSR 21 CFR Part 820 -- Quality System Regulation).
- Regulatory Compliance: Ensure all products meet regulatory requirements for Class IIa and IIb medical devices under EU MDR and Class II medical devices under US FDA.
- Audits and Inspections: Lead internal and external audits, including those by regulatory bodies, and ensure timely resolution of any findings.
- ISO 13485 Certification Audits: Manage yearly certification audits by a notified body to maintain ISO 13485 compliance.
- Customer Audits: Oversee and host audits conducted by global customers, ensuring all requirements are met.
- Documentation: Oversee the preparation and maintenance of quality documentation, including SOPs, work instructions, and quality records.
- Continuous Improvement: Drive continuous improvement initiatives to enhance the QMS of the site, product quality, and operational efficiency.
- Team Leadership: Manage and mentor a team of quality assurance professionals, fostering a culture of quality and compliance.
- Innovative Environment: Work with cutting-edge technology and a team of dedicated professionals.
- Global Impact: Play a key role in ensuring the safety and efficacy of medical devices used worldwide.
- Stakeholder Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality standards are met throughout the product lifecycle.
- Training: Develop and deliver training programs on quality standards and regulatory requirements for staff.
- Travel: Ability to travel to the US, UK, and EU as required for audits, inspections, and collaboration with global teams. (20% travel if on site, 50% if remote).

**What you´ll bring**
- Successfully completed Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences). Advanced degree preferred.
- Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline
- Minimum 10 years of experience, ideally in regulatory affairs or in quality management systems within the medical device industry.
- Certifications: EU MDR Certification for Class IIa and IIb medical devices; US FDA Class II medical devices.
- Skills: Strong knowledge of global regulatory requirements, excellent communication and leadership skills, proficiency in quality management software, ERP, and PLM systems.
- Work experience in an international and multicultural environment.
- Excellent project management and leadership skills.
- Ability to collaborate with business partners across multiple functions.
- Planning and organization skills.
- Strong communication skills - written, verbal and presentation.
- Competent in problem solving, team building, planning and decision making.
- Attention to detail.
- Commercially aware.
- Strong user experience Mircosoft suite.
- Languages: English and German are mandatory any other language will be