Staff Quality Assurance Scientist

Danaher • Chaska, MN

42d • $110,000 - $130,000 • Onsite

About The Position

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 Staff Quality Assurance Scientist is responsible for leading and facilitating escalations; will also have opportunities to participate in risk management and trending projects. This position reports to the PostMarket Quality Assurance Manager and is part of the Immunoassay Complaint Handling Unit, located in Chaska, Minnesota and will be an on-site role. In this role, you will have the opportunity to: Coordinate complaint management and PostMarket QA within the Complaint Handling Unit (CHU), including performing trending analyses and facilitating related review meetings Lead and facilitate cross-functional technical and/or strategy meetings across product lines Author CAPA requests and represent the CHU at CAPA Review Board (CRB) meetings Mentor and coach team members within and outside of the department Represent the company during regulatory audits

Requirements

• Degree in Science or Engineering or equivalent
• Experience in a similar technical/quality environment. (9 years with Bachelors degree or 7 years with Masters degree)
• Good troubleshooting experience
• Project management experience an advantage
• Knowledge of Beckman products an advantage

Nice To Haves

• Complaint investigation and regulatory reporting assessments
• Expert level of knowledge of industry standards and regulations
• Demonstrated diagnostic commercial product knowledge

Responsibilities

• Coordinate complaint management and PostMarket QA within the Complaint Handling Unit (CHU), including performing trending analyses and facilitating related review meetings
• Lead and facilitate cross-functional technical and/or strategy meetings across product lines
• Author CAPA requests and represent the CHU at CAPA Review Board (CRB) meetings
• Mentor and coach team members within and outside of the department
• Represent the company during regulatory audits

Benefits

• 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.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees