Sr. QE for Design Quality – Lifecycle Management

Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. 

Responsibilities

• Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management:
  • Ensure compliance with company policies and procedures.
  • Perform design control and risk management activities according to AbbVie's Quality System
  • Maintain DHF documentation
  • 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
• Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
• Support equipment qualifications (IQ/OQ/PQ) and process validations
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closure
• 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