Job description

Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions.
With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery.
As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence. Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

The Staff Quality Assurance for Beckman Coulter Diagnostics will represent quality assurance on development teams, quality system integration and product improvement projects for Beckman Coulter Life Science. Products supported include ValitaCell cell
viability and screening products.
Candidates who apply to understand of quality systems, design controls, industry standards and lifecycle processes to product development, manufacturing and quality system integration.
You will assure compliant process conformance and product documentation, inclusive of Design History, Product, and Process documentation in support of product realization and commercialization within the Beckman Coulter quality system..
This position is based in Dublin Ireland and will be hybrid on site 2-3 days per week.

In this role, you will have the opportunity to:
Coach teams with the application of ISO 9001 and quality systems processes throughout the product lifecycle.
Partner cross-functionally to ensure product conformance to requirements of ISO 9001 with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), and production controls.
Able to identify, develop and execute quality system, product and process improvements. Drives change cross-functionally across multi-site operations.

The essential requirements of the job include:
Able to facilitate implementation, training and support of quality system activities across sites and functions including CAPA, non-conforming processes, product and manufacturing process and supplier qualification activities.
Aware of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance.
Able to identify, develop and execute quality system, product and process improvements. Drives change cross-functionally across multi-site operations.

Position Qualifications:
BS Degree in biology, chemistry, chemical engineering or other science or related field; or equivalent experience required.
MS Degree or higher preferred.
BS+5 or MS+3 years’ experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, or related life sciences products.
Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired.

At Beckman Coulter Life Science we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter can provide.
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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