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Quality System Specialist (Qms)

6+ 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: Quality System Specialist
Location: Bangalore, India (On-Site with Flexible Work Options)


About HemoCue

For over 35 years, HemoCue has led the way in point-of-care testing, delivering accurate, reliable, and fast solutions where healthcare meets the patient. Our unwavering conviction that “it must be possible” drives us to innovate and deliver the highest standards of care. Join our mission to make the impossible possible and achieve remarkable results in a supportive and collaborative environment.

As part of Danaher, we collaborate with a global community of diagnostics companies to address the world’s most pressing health challenges.


Role Overview

The Quality System Specialist will support HemoCue in maintaining and improving its Quality Management System (QMS). This role is integral to ensuring compliance with certifications, managing audits, and overseeing document control processes. Reporting to the Director of Quality Systems at HemoCue AB in Sweden, this role is part of the Quality System Team located at the India Development Center (IDC) in Bangalore.

If you excel in a fast-paced, cross-functional environment and aspire to build a world-class quality system organization, this opportunity is for you.


Key Responsibilities

  • Manage changes to the Quality Management System, ensuring adequate control and oversight prior to implementation.
  • Provide Quality System expertise to support various organizational functions.
  • Coordinate activities related to quality certifications and audits.
  • Support the organization in ensuring adherence to applicable standards and regulations.

Essential Qualifications

  • Education: University degree in Science or Technology.
  • Experience:
    • 6+ years in a similar role within the medical device or related industry.
    • Expertise in standards and regulations such as ISO 13485, Quality System Regulations for Medical Devices, and ISO 14971 (Risk Management for Medical Devices).
  • Communication: Proficient verbal and written English skills.

Preferred Qualifications

  • Experience in conducting Quality Audits.

Why Join HemoCue?

At HemoCue, we are committed to making healthcare solutions simpler, better, and right. Joining our team means becoming part of a culture that fosters positivity, engagement, and innovation.

You’ll also benefit from being part of Danaher, a global leader in life sciences, diagnostics, and biotechnology. Danaher offers unparalleled opportunities for growth, collaboration, and impact, with a commitment to diversity and inclusion at its core.


Apply Now

Be part of a team that’s accelerating the impact of science and technology to improve patient lives worldwide. Visit www.danaher.com to learn more and apply.

Diversity Commitment

Danaher values diversity in all forms, embracing the unique perspectives and attributes that make each individual valuable. We are an equal opportunity employer, fostering inclusion, equity, and innovation.