Quality Assurance Specialist
23 hours ago
About the Role
This is an exciting opportunity to join Abbott's Diabetes Care division as a Quality Assurance Specialist. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products and processes.
Key Responsibilities
- Lead and support internal and external audits to maintain compliance with regulatory requirements.
- Develop and implement audit readiness plans to ensure timely closure of audit cycles.
- Collaborate with cross-functional teams to identify and mitigate compliance risks.
- Support the management of near miss incidents and track regulatory updates.
- Prepare and analyze metrics data to inform quality and compliance initiatives.
- Provide training and awareness programs to promote quality and compliance within the division.
Requirements
- AS or BS degree or equivalent combination of education and experience.
- 5+ years of experience in the medical device industry, with a focus on quality assurance and regulatory compliance.
- Excellent writing and communication skills, with experience working in a matrixed environment.
- Ability to work independently and as part of a team, with strong organizational and follow-up skills.
- Lead Auditor Certification for ISO 13485 or 9001:2000 is a plus.
About Abbott
Abbott is a global healthcare leader that helps people live more fulfilling lives. Our Diabetes Care division is dedicated to helping people with diabetes manage their condition and live healthier lives. We're committed to innovation, quality, and customer satisfaction.
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