Senior Quality Systems Specialist

vor 3 Wochen

Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Senior Quality Systems Specialist for Beckman Coulter Diagnostics is responsible for s upplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development.

This position is part of the Quality Assurance department located in Munich and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Quality Systems team and report to the Senior Manager Quality Systems responsible for the integrity of products received and shipped out, services provided to clients, compliance with government regulations, industry and OpCo standards. If you thrive in a fast paced, supporting role and want to work to build a world-class Quality organization—read on.

**In this role, you will have the opportunity to**:
Manage process and product non-conformances in line with company procedures, conduct quality assurance tests to ensure product specifications are met, and review, investigate, resolve and report on quality discrepancies

Develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards

Coordinate the Internal Audit Programs for Munich and other locations: ensure smooth audit completion and manage audit documentation

Manage internal audit relevant investigation, corrections / corrective actions planning and timely completion

Acquire eQMS expertise and support the audit process stakeholders in eQMS documentation

Train relevant WITS associates on audit process and eQMS

Coordinate external audits for Munich and other sites and manage au dit relevant corrections / corrective actions

Manage performance indicators for Internal and External Audit process

Support QSMR activities

**The essential requirements of the job include**:
Masters (Life Sciences) with several years of experience in Quality Management

Sound knowledge of regulatory requirements for Medical Device Quality Management - ISO 13485, ISO 14971, 21 CFR Part 820, IVDD / IVDR

Experience in Non-conformance / Deviation / CAPA Management

Experience in implementation of Good Documentation Practices, 21 CFR Part 11

Proficient English writing and verbal communication skills; German is a plus

**It would be a plus if you also possess previous experience in**:
Certified Internal / Lead auditor for Medical Device Quality Management

Completed Implementation course for ISO 13485

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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