Senior Quality Engineer, Design Quality - Late Stage Development
AbbVie
4 hours 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 QA activities related to Combination Product and Medical Device Development.
- 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) and design change control requirements are met.
- Perform 3rd party supplier management activities (e.g., 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.
- Independently initiate assignments; lead/participate in development and process improvement teams; anticipate/resolve quality issues and take preventative actions.
- Monitor effectiveness of processes and quality of project 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., ensuring thorough completion and accurate documentation.
- Participate in departmental Change Control activities; 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 cross-functional teams to drive change and continuous improvement.
Qualifications
- 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.
- Strong problem solving and analytical skills.
- Good interpersonal/communication skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing.
Responsibilities
- Ensure compliance with company policies and procedures.
- Perform QA activities related to Combination Product and Medical Device Development.
- 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) and design change control requirements are met.
- Perform 3rd party supplier management activities (e.g., 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.
- Independently initiate assignments; lead/participate in development and process improvement teams; anticipate/resolve quality issues and take preventative actions.
- Monitor effectiveness of processes and quality of project 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., ensuring thorough completion and accurate documentation.
- Participate in departmental Change Control activities; 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 cross-functional teams to drive change and continuous improvement.
Qualifications
- 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.
- Strong problem solving and analytical skills.
- Good interpersonal/communication skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing.