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, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Our location in Waukegan, IL currently has an opportunity for a Business Analyst to support Compliance/Products in the Digital Products team. The Business Analyst will own the delivery of quality documentation and also, be a part of the product team to build features to support external customers.
WHAT YOU'LL DO
Review, analyze, and evaluate business systems and user needs.
Document requirements, defines scope and objectives, and formulates systems to parallel overall business strategies.
Familiar with relational database concepts, and client-server concepts.
Generally supports Business Analyst, Compliance, testing and DevOps teams
Accountable for analyzing product impacts and include responsibilities around documenting and delivering on Abbott's compliance documentation, policies and procedures for Digital Products.
Lead the compliance process from inception to release and not just limited to product lifecycle documents
Manage risks, lead cross functional partnership, and ensure the deliverables from all integrated team
Lead Quality documentation processes required for the program and for Product as a Medical device
Support bringing up the rest of organization to embrace Product as a Medical device.
Manage scope & changes for the program and manage all levels of communication within the team to control scope creep
Support development of test plans to ensure that all objectives are met
Support and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product.
Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved.
Support business teams to Investigate customer complaints and product issues.
Must stay razor focused on goals, and lead meetings/conversations to successful outputs
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
EDUCATION AND EXPERIENCE YOU'LL BRING
Bachelor degree required
7+ years of experience in a similar role within the medical device industry, including MDR and/or EU MDR submission experience
Ability to work in a highly matrixed and geographically-diverse business environment.
Demonstrated leadership skills and experience, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Previous experience working in a broader enterprise/cross-division business unit mode
Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
Minimum 4 years of Quality Management System (QMS) management experience in the medical device industry
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.