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.

The Barkey product portfolio - medical heating technology - supports customers from all over the world.

Our international Quality team is looking for a Quality Assurance Manager (m/f/d) medical heating technology onsite in Griesheim (Darmstadt), Germany.

Travel activity: 20% travel (Europe, US, International)

How you`ll add value

We are looking for a highly experienced and motivated Quality Assurance Manager (m/f/d) to join our global Quality team. You will be responsible for our Barkey products portfolio focusing on medical heating technology. As an ideal candidate, you will have over 10 years of experience in managing quality systems for medical devices, with a strong focus on compliance with EU MDR and US FDA regulations.

This role will be based at our facility in Griesheim (Darmstadt), Germany and will involve overseeing quality assurance activities on a global scale.

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.
• ERP and PLM Systems: Utilize global ERP and product lifecycle management (PLM) applications to support quality management processes.
• 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 appreciated.
• Willingness to regional and international business travel.

Our Offer

• Become part of a company that makes a positive contribution to launching groundbreaking scientific developments and therapies.
• Contribute to innovative cell therapies and be a part of revolutionary cancer therapies.
• Take advantage of the operational opportunities in a growing, modern, and innovative company within the health care/life science industry.
• Experience an intensive exchange of experiences and close cooperation in a worldwide network with our customers, friends and partners.
• We offer participation in national and international company events.
• After your initial training, you will receive regular training and further education opportunities that are tailored to your needs.
• A workplace that promotes your maximum.
• You will participate in capital-forming benefits, numerous corporate benefits.
• 30 days of vacation.
• Positive corporate culture and practiced teamwork across all locations.
• Individual development opportunities of your international competencies and language skills.

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/

Contact

Azenta Germany GmbH (part of Azenta Life Sciences)

Christina Knappe (Senior Recruiter Central Europe)

christina.knappe@azenta.com