Lifecycle QA Design Transfer Lead - Med Devices

Mindlance; Waukegan (IL); On-site; USD 100,000 - 130,000; Full time

Job summary

Mindlance is seeking a Manager for Design Quality to ensure compliance in medical devices lifecycle. The role requires 8+ years in the industry, focusing on quality assurance and regulatory compliance for products like infusion pumps and autoinjectors.

The ideal candidate will have a technical degree, substantial experience in QA, and strong leadership skills to operate across teams effectively. The position is based in North Chicago, IL, and may require limited travel.

Qualifications

• 8+ years of relevant experience in the medical device or combination product industry.
• 5+ years of Quality Assurance experience required.
• Proven ability to lead cross-functional teams effectively.

Responsibilities

• Primary driver for quality and compliance in product transfer.
• Lead/support process validation activities like IQ/OQ/PQ.
• Manage on-market design changes and collaborate with cross-functional teams.

Skills

Medical Devices knowledge

FDA/EU regulations

Interpersonal skills

Project management

Education

Bachelor’s degree in engineering, science, or other technical areas

Advanced degree preferred

ASQ certification preferred (CQA, CQE, SSBB)

Tools

ISO 13485

ISO 14971

21 CFR 820

Job description

Mindlance is seeking a Manager for Design Quality to ensure compliance in medical devices lifecycle. The role requires 8+ years in the industry, focusing on quality assurance and regulatory compliance for products like infusion pumps and autoinjectors.

The ideal candidate will have a technical degree, substantial experience in QA, and strong leadership skills to operate across teams effectively. The position is based in North Chicago, IL, and may require limited travel.