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Product Quality Analyst

Sylmar, California1 openingPosted September 18, 2023
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

This position works out of our Sylmar, California location in the Abbott Cardiac Rhythm management division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

As a global leader in Cardiac Rhythm Management, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Abbott Cardiac Rhythm Management solution comprises an extensive portfolio of products designed to help you provide a complete management continuum and keep your heart healthy.

Job Summary:

This role involves analyzing and resolving technical and clinical inquiries regarding Abbott products, collaborating with engineering, and actively participating in product improvement and regulatory teams. It requires strong technical competence, communication skills, and interface with healthcare professionals.

Key Responsibilities:

  • Analyze and resolve technical and clinical inquiries from Abbott product customers.
  • Correspond with customers regarding inquiry results and product analysis.
  • Exercise discretion in escalating unusual product performance issues and collaborate with engineering to resolve customer complaints.
  • Actively participate in product improvement teams, field failure analysis, and other analytical teams to enhance products and address regulatory issues.
  • Demonstrate a high degree of technical competence and effective communication to receive, evaluate, investigate, and respond to customer questions and complaints.
  • Interface with healthcare professionals such as doctors, nurses, biomedical technicians, purchasing agents, materials managers, and risk managers to document, investigate, and correct field-related problems.
  • Communicate customer concerns and complaints to individuals managing databases and analyze data to identify trends, product needs, and service enhancements, and communicate findings to relevant personnel.
  • Perform product complaint documentation, investigation, customer response, and consulting activities on Abbott products, authoring correspondence to customers addressing complaint investigations.
  • Serve as a liaison between business units for quality and technical concerns as needed.

Qualifications:

  • Bachelor's degree in healthcare, science, technical fields, or related engineering field.
  • Preferably 1-2 years of medical device experience.
  • Biomedical Engineering background preferred.
  • Regulatory experience is a plus.
  • Knowledge of global regulations for medical device reporting and medical terminology is advantageous.
  • Strong written and oral communication skills.
  • Ability to work both independently and in teams within a fast-paced, changing environment.
  • Strong problem-solving and computer skills.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to multitask, prioritize, and meet deadlines in a timely manner with attention to detail.
This job description will be reviewed periodically and is subject to change by management.

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