Senior Quality Assurance Engineer

Danaher Corporation • Miami, FL

5d

About The Position

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 Senior Quality Assurance Engineer is part of the Miami Process Validation Group, specializing in all types of validation deliverables. Located in Miami/Hialeah, the role involves travel between sites, contributing to an environment of impeccable compliance that provides a competitive advantage to our partners. The Quality Assurance engineer is a key member of the Miami PV team, located in Miami, reporting to the Senior Manager, Process Validation. You will collaborate with senior QA staff, taking responsibility for Process Validation & QA Instrument Shared Services within instrument manufacturing. If you thrive in a constantly changing, multitasking role and are eager to build a world-class Process Validation / Instrument QA organization, we encourage you to apply. In this role, you will have the opportunity to: Write and conduct IOQ and spreadsheet validations. Complete PQ, TMV, AQ, and NPSV validations. Manage process and product non-conformances in line with company procedures. Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.

Requirements

• Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry.
• Familiarity with CFR 21 Part 820 and ISO13485.
• Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.

Nice To Haves

• Knowledge of PQ, TMV, AQ, NPSV validations.
• Exposure to Gamp5 or similar regulations.
• ASQ Certified Quality Engineer (CQE).

Responsibilities

• Write and conduct IOQ and spreadsheet validations.
• Complete PQ, TMV, AQ, and NPSV validations.
• Manage process and product non-conformances in line with company procedures.
• Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees