Quality Manager (m/f/d)

Company Description

ABOUT LGC BIOSEARCH TECHNOLOGIES:

With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organisation.

Job Description

Join Our Team in Berlin as a Quality Manager (m/f/d)

Are you ready to take the next step in your career and make a significant impact? We are seeking a dedicated Quality Manager to join our team in Berlin. This role is essential in ensuring that our quality management systems not only meet but exceed standards, encouraging a culture of continuous improvement and compliance.

Key Responsibilities

• Collaboratively coordinate, improve, and ensure compliance with all applicable internal specifications and processes to uphold ISO 9001 certification, within a unified Quality Management (QM) framework.
• Assume responsibility as the EU Authorised Representative in accordance with EU Directive 2006/42/EC (EU Machinery Directive) and internal processes.
• Lead all aspects of Quality Management System (QMS) documents and records, including the review and approval of changes to both documents and non-documents.
• Build and lead non-conformance and non-conformity reports, conduct audits, and handle customer complaints to ensure compliance with ISO 9001 requirements.
• Oversee and upkeep the etq (eQMS) system, including the CAPA system. Conduct CAPA status meetings as required to facilitate progress and assess implemented measures.
• Collect and analyse data on quality target metrics and other important performance indicators.
• Be responsible for and present management reviews, ensuring detailed analysis and clear communication of quality performance.
• Conduct annual document reviews to ensure all documents are current and compliant.
• Liaise with management to handle quality agreements with customers, ensuring compliance and accurate notification.
• Independently conduct external and internal audits, from planning to reporting.
• Organise quality orientation training courses for all employees.
• Supervise change control and complaint management processes.
• Collaborate with other departments to create and regularly update process descriptions, SOPs, QMLs, and QMFs in accordance with QM specifications.
• Assist in the risk analysis of critical QM processes.
• Prepare monthly reports for global management and represent the quality management function in site meetings.
  
  

Qualifications

Your Profile

• Educational Background: A completed apprenticeship (Ausbildung) or university degree in a biological / life sciences or related discipline—or equivalent expertise.
• Professional Experience: Proven experience in a leadership role within quality management in medical devices, biotechnology, or pharmaceuticals and ISO 13485 certification.
• Language Skills: Fluency in German and a good level of English is a must.
  
  

Why Join Us?

This is more than just a job; it’s an opportunity to be a part of a mission-driven organisation committed to making a safer world through science. You will have the chance to drive meaningful change, work with a dynamic team, and contribute to the high standards that our company is known for.

Ready to make an impact? Apply now and join us on our journey to excellence in quality management. 🚀

Additional Information

ABOUT LGC:

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

OUR VALUES

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT
  
  

EQUAL OPPORTUNITIES

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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