Cardiovascular Medical Device Quality Leader

Custom Search Inc.; Minneapolis (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

Custom Search Inc. seeks a Manager of Quality to lead hands-on QMS across a cardiovascular medical device program, guiding regulatory readiness and ISO certification as development advances toward commercialization.

You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to strengthen the quality system in a lean startup environment. The role focuses on executing design controls, risk management, and CAPA, while coordinating with FDA and external auditors.

Qualifications

• Bachelor's degree in life sciences, engineering, or related field.
• Significant medical device quality experience in QMS operations and cross-functional projects.
• Experience with Class II and III devices and regulatory submissions is ideal.

Responsibilities

• Manage day-to-day operation and continuous improvement of the QMS, incl. electronic QMS, controlled documents, procedures, and workflows.
• Lead quality system certification prep, internal audits, management reviews, CAPA, and inspection readiness; coordinate responses and follow-up actions.
• Partner with R&D and Manufacturing on design controls, risk management, verification/validation, manufacturing controls, and validation master planning.
• Support supplier qualification, supplier quality activities, and product quality with manufacturing quality personnel.
• Collaborate with FDA, auditors, consultants, and external partners; identify compliance risks and practical solutions.
• Coordinate cross-functional projects, priorities, and resources, guiding quality for commercialization readiness.

Skills

Quality management

Cross-functional collaboration

Regulatory experience

Education

Bachelor's degree in life sciences or engineering

Tools

Quality Management System (QMS)

ISO 13485

Job description

Custom Search Inc. seeks a Manager of Quality to lead hands-on QMS across a cardiovascular medical device program, guiding regulatory readiness and ISO certification as development advances toward commercialization.

You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to strengthen the quality system in a lean startup environment. The role focuses on executing design controls, risk management, and CAPA, while coordinating with FDA and external auditors.