Senior Design Quality Engineer — Lifecycle & Transfer

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 79,000 - 141,000; Full time

Job summary

AbbVie is seeking a Senior Quality Engineer- Design Quality – Lifecycle Management in North Chicago, IL, to lead QA on design transfer and lifecycle activities for medical devices and combination products. You will ensure compliance, maintain DHF, and support regulatory submissions while partnering with Quality and Operations to drive design changes and continuous improvement.

The role requires a Bachelor's in Biology, Chemistry or Engineering and 6+ years in manufacturing or quality.

Qualifications

• Bachelor's degree 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 relations / communications 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 Design Transfer and Change Management.
• Ensure compliance with company policies and procedures; perform design control and risk management activities.
• Maintain DHF documentation.
• Partner with Quality and Operations to ensure design control documentation and change control requirements are met.
• Perform third party supplier management activities such as review third party design control activities.
• Support the creation of regulatory submission documentation.
• Lead design transfer activities to enable product launches.
• Support equipment qualifications (IQ/OQ/PQ) and process validations.
• Own change plans to manage on-market design changes and monitor closure.
• Identify gaps/improvement opportunities within the DHF and Risk Management and track to closure.
• Lead/participate in investigations and CAPA reviews.
• Write and revise procedures, forms, and related documents.
• Work with cross-functional teams to drive change and continuous improvement.

Skills

Quality systems

Design transfer

Risk management

Regulatory compliance

Cross-functional teamwork

Analytical skills

Communication skills

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

AbbVie is seeking a Senior Quality Engineer- Design Quality – Lifecycle Management in North Chicago, IL, to lead QA on design transfer and lifecycle activities for medical devices and combination products. You will ensure compliance, maintain DHF, and support regulatory submissions while partnering with Quality and Operations to drive design changes and continuous improvement.

The role requires a Bachelor's in Biology, Chemistry or Engineering and 6+ years in manufacturing or quality.