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Senior Analyst - Design Quality Assurance

7+ years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Senior Analyst - Design Quality Assurance
Location: Beckman Coulter Life Sciences


About Beckman Coulter Life Sciences

Beckman Coulter Life Sciences, with over 80 years of experience, is a global leader in scientific innovation. As part of Danaher, we are driving the future of healthcare and science, providing groundbreaking solutions that empower our customers to transform the world.


Role Overview

We are seeking a Senior Analyst - Design Quality Assurance to join our Global Development Quality Assurance (QA) team. This role is essential for supporting New Product Development (NPD) and Design Changes, ensuring compliance with design control processes, and leading quality improvement projects.

As a Senior Analyst, you will monitor design control, track design defects, and guide the implementation of quality improvements throughout the product lifecycle.


Key Responsibilities

  • Ensure full compliance with design control processes across the entire product lifecycle.
  • Guide and support product design control processes and risk management processes.
  • Review and approve Design History Files (DHF).
  • Establish and maintain a robust Quality Management System (QMS) that meets regulatory requirements.
  • Monitor the performance of design control processes through data analysis.
  • Lead quality improvement projects to enhance process effectiveness and ensure product safety.
  • Provide quality training to team members and stakeholders.

Required Qualifications

  • Educational Requirements:

    • Bachelor’s or Master’s degree in Biotechnology, Medicine, Laboratory Science, Biology, Immunology, Pharmacy, or related fields.
  • Experience:

    • At least 7+ years of experience in reagent development, testing, or quality assurance supporting new project launches or design changes.
    • At least 3 years of experience in reagent design and development quality assurance roles.
    • Deep understanding of the quality control points of in vitro diagnostic (IVD) reagents design and development, including product principles and testing methods.
    • Familiarity with ISO 13485, GMP, and other quality management systems relevant to IVD product design control.
    • Proficiency in using quality tools for data analysis.
    • Fluent in English (both written and spoken).

Preferred Qualifications

  • Experience with CAPA (Corrective and Preventive Actions) and Risk Management processes.
  • Experience supporting core team QA across hardware, software, reagents, and combination products.
  • Experience with FDA audit preparation and having undergone FDA audits.

Why Join Beckman Coulter Life Sciences?

At Beckman Coulter Life Sciences, you’ll be part of a dynamic team committed to advancing healthcare through scientific innovation. Our team is dedicated to making a real impact on patient lives and supporting groundbreaking discoveries in diagnostics.

By joining us, you’ll play a key role in developing high-quality, safe products, while growing within a global organization that values excellence and innovation.


Apply Now

To learn more about this exciting opportunity and apply, visit www.danaher.com.

Diversity and Inclusion

At Danaher, we embrace the diversity of our workforce and are committed to creating an inclusive workplace. We value the unique perspectives that our associates, customers, and shareholders contribute, and we are an equal opportunity employer.