Senior Quality Engineer, Design Quality - Late Stage Development

AbbVie•Irvine, AZ

22h

About The Position

The Senior Quality Engineer is responsible for representing Quality Assurance on cross-functional combination product and medical device development teams. This role involves executing Quality System requirements to ensure that products developed, manufactured, tested, and procured, as well as data generated, are compliant with worldwide Combination Product and Medical Device Regulations.

Requirements

Bachelor's degree, preferably in Biology, Chemistry or Engineering
6+ years of overall experience in Manufacturing, Quality or Engineering
Good verbal and written communication skills
Good problem solving and analytical skills
Good interpersonal relations / communications skills
Good negotiation skills
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing

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