Posted in: Engineering in Chicago | Posted: |
Job Description
Purpose:
Responsible for representing 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. The role performs a variety of tasks related to monitoring of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820, MDR 2017/745, EN ISO 13485).
Responsibilities:
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 Operations 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 documentation
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
Lead/assist in the preparation of and support regulatory agency and internal audits.
Conduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc.
Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments.
Review and approve changes relevant to the department
Support interactions with regulatory authorities (e.g., Notified Body audits)
Write and revise procedures, forms, and other documents, as needed
Work with the cross-functional team to drive change and continuous improvement
