Manager, Design Quality- Lifecycle Management

Manager, Design Quality – Lifecycle Management
 
Contract Length: 12 months to start
Schedule: Hybrid (Monday and Friday Remote, Tuesday-Thursday onsite)
Rate: $91-$96/HR based on benefit selection
Location: North Chicago, IL


 
Orion Group is seeking a Manager, Design Quality – Lifecycle Management to support a global pharmaceutical and medical device organization.
 
This position serves as the Quality Assurance lead supporting lifecycle management activities for medical devices and combination products (MDCP), ensuring compliant product transfer from development to manufacturing and sustained quality for on-market products.
 
The Manager, Design Quality will represent QA on cross-functional teams and drive design transfer, design change control, and process validation activities while ensuring alignment with global regulatory requirements and internal quality systems.
 
 Key Responsibilities

• Serve as primary Quality lead for design transfer activities, enabling successful product launches across internal and external manufacturing sites.
• Lead and support on-market design changes, ensuring adherence to Design Control and Change Control principles.
• Drive process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Own lifecycle change plans, conduct impact assessments, and ensure timely execution and closure.
• Ensure completeness of Design History File (DHF), Traceability, and Risk Management documentation.
• Support third-party suppliers during change management activities.
• Identify gaps within quality systems and lead cross-functional process improvement initiatives.
• Support regulatory inspections and internal audits as a QA subject matter expert.
• Partner with suppliers, contract manufacturers, and global sites to maintain compliance and ensure high-quality product lifecycle execution.
• Lead investigations and review boards related to CAPAs, Change Plans, NCRs, and Observations.
• Contribute to global Product Quality Assurance strategy for device and combination products.

 
 Required Qualifications

• Bachelor’s degree in Engineering, Science, or related technical discipline (Advanced degree preferred)
• 8+ years experience in medical device or combination product industry
• 5+ years Quality Assurance experience
• Experience leading design transfer and lifecycle design change initiatives
• Strong cross-functional leadership and influence skills

 
Strong working knowledge of:

• ISO 13485
• ISO 14971
• 21 CFR 4
• 21 CFR 820
• EU MDR (2017/745)

 
Experience with medical devices such as:

• Infusion Pumps
• Pre-filled Syringes (PFS)
• Autoinjectors
• On-Body Injectors

 
 


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.