(USA) Quality Assurance/Systems Manager (Import, Regional, Returns, Wm.Com) - job 20 of 35

Job Description Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings.By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.• Primarily responsible for representing Quality Assurance (QA) on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.• Perform QA activities related to Combination Product and Medical Device Development :• Ensure compliance with company policies and procedures.• Perform design control and risk management activities according to AbbVie's Quality System• Partner within Quality and Research & Design (R&D) to ensure design control documentation (Risk Management, Traceability / Linkages) & design change control requirements are met• Perform 3rd party supplier management activities such as review 3rd party design control activities• Support the creation of regulatory submission documentationQualifications• Bachelor's degree or equivalent is required; preferably in sciences, engineering or other technical / scientific area.• 4+ years of industry experience in Quality Assurance, Development or healthcare related field. Less experience considered with advanced degree.Medical device experience required. Combination Product and 3rd party supplier management experience desired."Additional InformationWe offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical / dental / vision insurance and 401(k) to eligible employees.This job is eligible to participate in our short-term and long-term incentive programs.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.htmlLast updated : 2024-07-29