Senior Quality Analyst - Unterschleißheim, Deutschland - Beckman Coulter Diagnostics

Beschreibung

Curious about what lies within BeckmanCoulter Diagnostics? Let's delve in.

Take a closer look, and it's clear that for over 80 years, we've been dedicated to advancing and optimizing the laboratory to propel science and healthcare forward. Join a team where your voice matters, support is given, and authenticity is valued. We're fostering a culture that embraces the various backgrounds, experiences, and viewpoints of all our team members. Dig deeper, and you'll discover our commitment to your growth, providing ample opportunities to forge a rewarding career, unleash creativity, and explore new horizons with the backing needed for success.

Beckman Coulter Diagnostics takes pride in collaborating with a network of six other Diagnostics Companies within Danaher. Together, we're at the forefront of change, striving to enhance patient outcomes through diagnostic solutions that tackle the most pressing health challenges globally.

As a Senior Quality Analyst at Beckman Coulter Diagnostics, you'll play a pivotal role in driving Quality Management initiatives that significantly impact the organization. Reporting to the Senior Manager overseeing Quality Systems management.

This role is based in the Quality Systems department in Munich, Germany, offering flexible, hybrid work arrangements.

If you thrive in a dynamic environment that blends multiple functions and are passionate about Quality Management, while aiming to contribute to building a top-tier Quality organization- keep on reading.

In this role, you will have the opportunity to:

Quality System Management Support:

• Support the management of QSMR through planning, organization, and documentation, along with QSMR action tracking.
• Assist in External Audit Management encompassing planning, real-time audits, and post-audit activities.
• Take charge of Quality System matters such as responding to audit findings and QMS document reviews.

CAPA Management:

• Oversee CAPA activities from problem statements to root cause analysis, implementing corrective and preventative actions, tracking timelines, and establishing CAPA files.
• Evaluate the effectiveness of the CAPA system.
• Provide support or deliver training on tool usage including SMARTSOLVE, EDMS, and MasterControl.

The essential requirements of the job include:

• Holder of a Bachelor's or Master's degree in Engineering or a Science-related field.
• More than 6 years of experience in Quality Management Systems within the Pharma or Medical Device industry.
• Familiarity with ISO 13485, IVDR, 21 CFR Part 820, and 21 CFR Part 11.
• Strong Quality Documentation skills (proficiency in Good Documentation Practices).
• Ability to work autonomously.
• Mandatory proficiency in English, with knowledge of German being advantageous.

It would be a bonus if you also have prior experience in:

• Electronic Documentation Management involving GxP Tools and MS Office.
• Exposure to Certification body / FDA audits.

At Danaher, we fuse science, technology, and operational expertise to expedite the tangible impact of future science and technology. We collaborate with clients worldwide to tackle their most intricate challenges, crafting solutions that bring the essence of science to life. Our global teams are leading the way in Life Sciences, Diagnostics, Biotechnology, and beyond. For more details, visit the official website.

At Danaher, we cherish diversity; acknowledging both the similarities and differences, visible and unseen, present within our workforce, workplace, and the markets we engage with. Our team members, customers, and stakeholders enrich our collective perspectives with their unique attributes.