Senior Quality Engineer, Design Quality - Late Stage Development
AbbVie
2 months ago
Remote friendly (North Chicago, IL)
United States
Operations
The Senior Quality Engineer is 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.
Responsibilities:
- Ensure compliance with company policies and procedures.
- Perform design control and risk management activities according to AbbVie's Quality System.
- Partner with Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.
- Manage 3rd party suppliers, including review of 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.
- Independently initiate assignments; lead/participate in development and process improvement teams; anticipate/resolve quality issues and take preventative actions.
- Monitor effectiveness of processes and project quality work; propose and execute quality/process improvements.
- Apply knowledge of global regulations, guidance, and corporate/function standards.
- Lead/assist regulatory agency and internal audits.
- Conduct/lead/participate in investigations for IRRs, NCRs, Observations, etc.; ensure thorough completion and accurate documentation.
- Participate in departmental Change Control, performing design change impact assessments.
- Review and approve changes for late-stage development projects.
- Support interactions with regulatory authorities (e.g., Notified Body audits).
- Write and revise procedures, forms, and other documents as needed.
- Drive change and continuous improvement with cross-functional teams.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry or Engineering.
- 6+ years of experience in Manufacturing, Quality or Engineering.
- Good verbal and written communication skills.
- Good problem solving and analytical skills.
- Good interpersonal/communications skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
Application instructions:
- Not provided in the text.
Responsibilities:
- Ensure compliance with company policies and procedures.
- Perform design control and risk management activities according to AbbVie's Quality System.
- Partner with Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.
- Manage 3rd party suppliers, including review of 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.
- Independently initiate assignments; lead/participate in development and process improvement teams; anticipate/resolve quality issues and take preventative actions.
- Monitor effectiveness of processes and project quality work; propose and execute quality/process improvements.
- Apply knowledge of global regulations, guidance, and corporate/function standards.
- Lead/assist regulatory agency and internal audits.
- Conduct/lead/participate in investigations for IRRs, NCRs, Observations, etc.; ensure thorough completion and accurate documentation.
- Participate in departmental Change Control, performing design change impact assessments.
- Review and approve changes for late-stage development projects.
- Support interactions with regulatory authorities (e.g., Notified Body audits).
- Write and revise procedures, forms, and other documents as needed.
- Drive change and continuous improvement with cross-functional teams.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry or Engineering.
- 6+ years of experience in Manufacturing, Quality or Engineering.
- Good verbal and written communication skills.
- Good problem solving and analytical skills.
- Good interpersonal/communications skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
Application instructions:
- Not provided in the text.