Quality Assurance Supervisor

Beckman Coulter Diagnostics; Munster; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Benefits program

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Supervisor - Quality Assurance to manage the incoming inspection team on-site in Co. Clare. You will ensure GMP/compliance and timely release of materials to operations.

You will lead cross-functional teams, train inspectors on procedures and cGMPs, and drive quality metrics for continual improvement within the Operations Quality dept.

A BSc/MSc in a technical field and 3+ years in an FDA-regulated industry are required.

Qualifications

• 3 years’ experience in an FDA‑regulated industry.
• Excellent time management and organisation skills.
• Effective interpersonal and verbal/written communication skills.
• Strong proofreading skills with emphasis on attention to detail.

Responsibilities

• Ensure all Incoming Inspection activities are completed with accuracy and compliance.
• Participate in cross‑functional teams, providing Incoming Inspection support to all departments, ensuring GMP and Quality System Regulations are complied with during the ordering and receipt of product.
• Ensure supplier‑related quality issues identified through the receiving or incoming inspection process are effectively prioritised and acted upon in a timely manner, particularly those in the NC / SCAR process.
• Management of, communication with, and development of area personnel, including training inspectors on procedures, cGMPs, and documentation control
• Generate, analyse, and report quality metrics to relevant personnel to ensure ongoing improvement programs are put in place.

Skills

Time management

Organization

Communication

Proofreading

Education

BSc/MSc in Chemistry

Tools

Lean methodologies

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

The Supervisor -Quality Assurance for Beckman Coulter Diagnostics is responsible for activities related to receiving / goods inwards, processes. You will be responsible for managing the incoming inspection team, while supporting timely release of materials to operations & ensuring compliance.

This position reports to the Senior Manager, Quality Assurance and is part of the Operations Quality dept located in Co. Clare and will be an on-site role.

In This Role, You Will Have The Opportunity To

• Ensure all Incoming Inspection activities are completed with accuracy and compliance.
• Participate in cross‑functional teams, providing Incoming Inspection support to all departments, ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the ordering and receipt of product.
• Ensure that supplier‑related quality issues identified through the receiving or incoming inspection process are effectively prioritised and acted upon in a timely manner, particularly those in the NC / SCAR process.
• Management of, communication with, and development of area personnel, including training inspectors on procedures, cGMPs, and documentation control
• Generate, analyse, and report quality metrics to relevant personnel to ensure ongoing improvement programs are put in place.

The Essential Requirements Of The Job Include

• B.Sc. or M.Sc. in Chemistry, Biochemistry, Microbiology, Engineering, or another relevant technical field, with at least 3 years’ experience in an FDA‑regulated industry.
• Excellent time management and organisation skills and working on own initiative.
• Effective interpersonal and verbal/written communication skills
• Strong proof-reading skills with emphasis on attention to detail

It would be a plus if you also possess/have previous experience in:

• Experience in Quality in the medical device industry
• Are familiar with lean methodologies (such as DBS)

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.