Senior Design Quality Lifecycle Manager (Hybrid)

Stark Pharma; Lakewood (IL); Hybrid; 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

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.