Hybrid Design Quality Manager — Lifecycle & Transfer Lead

Us Tech Solutions; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A global staff augmentation firm is seeking a Manager, Design Quality to ensure compliance and quality in medical device production. Responsibilities include driving quality during product transfers, leading process validations, and supporting regulatory audits. The ideal candidate holds a Bachelor's degree in engineering or science, has over 8 years of experience in the medical device sector, and possesses strong interpersonal and project management skills. This is a hybrid role with onsite and remote work opportunities.

Qualifications

• 8+ years of experience in the medical device industry; 5+ years in Quality Assurance.
• Knowledge of ISO standards and 21 CFR regulations.
• Working knowledge of infusion pumps and combination products.

Responsibilities

• Drive quality and compliance during product transfer.
• Lead process validation activities.
• Support regulatory inspections and audits.

Skills

Medical Device Knowledge

Regulatory Compliance

Interpersonal Skills

Project Management

Education

Bachelor’s degree in engineering or science

Advanced degree preferred

ASQ certification preferred (CQA, CQE, SSBB)

Job description

A global staff augmentation firm is seeking a Manager, Design Quality to ensure compliance and quality in medical device production. Responsibilities include driving quality during product transfers, leading process validations, and supporting regulatory audits. The ideal candidate holds a Bachelor's degree in engineering or science, has over 8 years of experience in the medical device sector, and possesses strong interpersonal and project management skills. This is a hybrid role with onsite and remote work opportunities.