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, and have a minimum of 8 years of experience in quality engineering, specifically within the medical device industry. Strong knowledge of regulatory requirements such as FDA regulations, ISO 13485, and risk management principles is essential. Experience with data management systems and cybersecurity protocols is also required.
The Senior Quality Engineer will perform Abbott Vascular data management 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 BTS on risk identification and mitigation activities, facilitate cross-functional team collaboration to achieve data management goals, support AV data management project plan and perform assessment and mitigation with cross functional team, develop and manage data management training program including training material and training audience, track and report data management metrics, provide support to internal and external audits, manage data management audit findings and CAPAs, continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices, and collaborate with AV key stakeholders, Abbott corporate functional groups, and other Abbott business units.
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.