Quality Assurance Specialist
2 days ago
Abbott Laboratories 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, nutritionals and branded generic medicines.
We're seeking a highly skilled Quality Assurance Specialist to join our team in Alameda, CA. As a key member of our Diabetes Care division, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities
- Lead and support internal quality audits to assess compliance with regulatory requirements.
- Support Audit Readiness activities for external audits, including training staff and providing guidance in preparation for external audits.
- Identify and manage compliance risks, and develop strategies to address compliance gaps.
- Assist in the management of our near miss program.
- Track and evaluate regulatory and industry standards revisions, and communicate the impact of these revisions with relevant departments.
- Prepare and review metrics data to promote awareness and understanding of quality and compliance within the division.
- Participate in compliance initiatives and other assigned projects.
- AS or BS degree or combination of appropriate education and experience.
- 5 years of experience in the medical device industry and 5 years auditing per ISO and/or FDA standards.
- Excellent writing skills and experience working in a broader enterprise/cross division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communication skills, with ability to effectively communicate at multiple levels in the organization.
- Ability to multitask, prioritize, and meet deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel, including internationally.
- Lead Auditor Certification for ISO 13485 or 9001:2000.
Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits. If you're passionate about quality and compliance, and want to make a difference in the lives of people around the world, we encourage you to apply.
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