Senior Quality Engineer, Design Quality - Late Stage Development at Abbvie

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager. 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. • Apply knowledge of global regulations, guidance, and Corporate and Function standards. • Lead/assist in the preparation of and support regulatory agency and internal audits. • Conduct, lead, or participate in investigations for IRRs, NCRs, Observations, etc; ensuring that investigations are completed thoroughly and documented accurately. • Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments. • Review and approve changes relevant to late-stage development projects. • 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.