Senior Quality Engineer – Design Transfer & Compliance

BioSpace; North Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

PTO & Holidays

Medical/Dental/Vision

401(k)

STI eligibility

Job summary

AbbVie is seeking a Sr. QE for Design Quality Lifecycle Management to ensure smooth transfer from development to manufacturing of medical devices and combination products.

You will lead design transfer activities, support IQ/OQ/PQ and process validations, drive CAPA and change control, and collaborate with regulatory bodies to maintain compliance worldwide.

This role requires strong collaboration with cross-functional teams and a proactive approach to quality improvements.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 6+ years in Manufacturing, Quality, or Engineering.
• Strong verbal and written communication.
• Strong problem solving and analytical skills.
• Good interpersonal, negotiation and collaboration abilities.
• Knowledge of quality/compliance regs affecting API, Bulk Drug or finished goods manufacturing.

Responsibilities

• Perform QA activities for Design Transfer and Change Management.
• Ensure compliance with policies; maintain DHF docs.
• Lead design transfer activities for product launches.
• Support equipment qualifications (IQ/OQ/PQ) and process validations.
• Lead CAPA investigations and change control.
• Collaborate with regulatory authorities and audits.

Skills

Verbal and written communication

Problem solving

Analytical skills

Interpersonal skills

Negotiation skills

Quality/compliance knowledge

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

AbbVie is seeking a Sr. QE for Design Quality Lifecycle Management to ensure smooth transfer from development to manufacturing of medical devices and combination products.

You will lead design transfer activities, support IQ/OQ/PQ and process validations, drive CAPA and change control, and collaborate with regulatory bodies to maintain compliance worldwide.

This role requires strong collaboration with cross-functional teams and a proactive approach to quality improvements.