Senior QA Clinical Specialist- Post Market
iRhythm Technologies- Full Time
- Senior (5 to 8 years)
Candidates should possess a Bachelor’s degree in Engineering, preferably Biomedical, Mechanical, or Chemical Engineering, and have at least 3 years of experience in quality engineering, specifically within a medical device or similar regulated industry. Strong understanding of quality systems, such as ISO 13485 and FDA regulations, is essential, along with experience in data integrity and risk management.
The Quality Engineer will perform Abbott Vascular quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. They will work closely with R&D, Equipment Engineering, Quality Engineering, and IT on risk identification and mitigation activities, facilitate cross-functional team collaboration to achieve data management goals, and support project planning by performing assessments and mitigations.
Healthcare solutions in diagnostics and devices
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.