Manager, Design Quality – Lifecycle Management

Stark Pharma Solutions Inc; Lakewood (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma is seeking an experienced Manager, Design Quality Lifecycle Management to oversee quality assurance for medical devices. The role involves leading compliance activities for product transfers, ensuring adherence to regulatory requirements, and collaborating across functional teams.

The ideal candidate will have at least 8 years of experience in the Medical Device industry and a Bachelor's degree in a technical field. Strong expertise in Design Controls, Change Management, and Risk Management is required.

Qualifications

• 8+ years of experience within Medical Device or Combination Product industries.
• 5+ years of Quality Assurance experience supporting regulated products.

Responsibilities

• Lead quality and compliance activities related to product transfer.
• Serve as the primary Quality lead for design transfer activities.
• Lead and support validation activities including IQ/OQ/PQ/PPQ.
• Drive lifecycle design change projects in accordance with requirements.
• Own change management plans, impact assessments, and execution strategies.

Skills

Design Controls

Change Management

Risk Management

Product Lifecycle Management

Validation activities (IQ/OQ/PQ/PPQ)

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Job Title: Manager, Design Quality Lifecycle Management

Location: Lake County, IL (Hybrid)

Duration: 12+ Month Contract

Job Summary

We are seeking an experienced Manager, Design Quality Lifecycle Management to support quality assurance and compliance activities for medical devices and combination products throughout product lifecycle management. This role will serve as the Quality representative on cross‑functional teams, ensuring successful product transfers, design changes, validation activities, and ongoing compliance with global regulatory requirements. The ideal candidate will have deep expertise in Design Controls, Change Management, Risk Management, and lifecycle quality support for medical devices and combination products such as infusion pumps, pre‑filled syringes, autoinjectors, and on‑body injectors.

Key Responsibilities

• Lead quality and compliance activities related to product transfer, commercialization, and on‑market lifecycle management
• Serve as the primary Quality lead for design transfer activities supporting internal and external manufacturing sites
• Lead and support validation activities including IQ/OQ/PQ/PPQ and Test Method Validation (TMV)
• Drive lifecycle design change projects in accordance with Design Control and Change Control requirements
• Own change management plans, impact assessments, execution strategies, and closure activities for on‑market product changes
• Ensure Design History File (DHF), traceability, and risk management documentation remain compliant and inspection‑ready
• Identify and drive remediation of gaps within design control, risk management, and quality system processes
• Support supplier and contract manufacturing quality activities during design and process changes
• Participate in regulatory inspections, audits, CAPA investigations, NCR reviews, and quality review boards as a Subject Matter Expert (SME)
• Collaborate cross‑functionally with Engineering, Manufacturing, Regulatory, Supply Chain, and external partners to ensure product quality and compliance
• Contribute to continuous improvement initiatives and development of quality procedures, policies, and best practices

Required Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline
• 8+ years of experience within Medical Device or Combination Product industries
• 5+ years of Quality Assurance experience supporting regulated products

Strong Expertise In

• Design Controls
• Change ControlRisk Management
• Product Lifecycle Management
• Validation activities (IQ/OQ/PQ/PPQ)

Experience Supporting Medical Devices And Combination Products Such As

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

Working Knowledge Of

• FDA 21 CFR Part 820
• FDA 21 CFR Part 4
• ISO 13485
• ISO 14971
• EU MDR (2017/745) and MDD requirements
• Strong project management, communication, and cross‑functional leadership skills