Title: QA Compliance Specialist
Location: Abbott Park, IL
Duration: 6+ Month and conversion to FTE
Job Description
- MD division - will direct all regulatory submissions, renewals, labeling, licensing for over 160 countries
- Will work with 4-5 shared groups with production release process, IT tools support, evaluations, IFU creation related to regulatory operations
- will provide quality management to several business units
- will work in a couple specific areas such as regulatory functions, CAPA, and will help with managing and issuing program metrics for reporting/administration
- will manage changes to existing and new regulations assessing the impact and will implement solutions based on impact
- will do an assessment of quality system process and document
- will create and manager procedure template for SH, EP, AVD, business units
- will manage process improvement
- will drive change and improvements
- must understand regulatory process and be quality system oriented/have a background in this
- Must come from medical device background/regulatory industry/pharma
- Must have 5 plus years of experience in these areas including quality system process and the ability to align the different business units to a regulation
- Must be able and experienced to write a process and procedures
Top 5 skills looking for:
- CAPA experience
- Document Control
- Continuous Improvement
- Regulatory understanding of functions
- Process Assessment
- Certification are preferred: ISO 9000, ISO 9001, ISO 13485
Education: Bachelor's degree required - advanced degrees preferred
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 and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.