Quality Manager — Medical Device QA & Regulatory Leader

Designhire; Racine (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Design Hire is seeking a Quality Manager to lead quality systems within a regulated manufacturing environment. This role emphasizes improving processes, supporting audits, and maintaining high standards across production and documentation.

Experience in medical device manufacturing and familiarity with FDA audits are strongly valued. The role requires hands-on leadership and collaboration with operations, engineering, and production teams to resolve quality issues and ensure products meet

Qualifications

• 5+ years of quality experience in a manufacturing environment.
• Prior quality leadership or management experience required.
• Medical device manufacturing experience strongly preferred.
• Working knowledge of FDA audit requirements and regulated quality systems.
• Experience with ISO 13485 preferred.
• Background supporting fabrication processes, inspection methods, and production quality controls.
• Strong understanding of corrective actions, root cause analysis, nonconformance handling, and documentation practices.
• Strong communication, organization, accountability, and cross-functional leadership skills.

Responsibilities

• Manage quality management activities across inspection, documentation, corrective actions, and process controls.
• Lead internal audit readiness and support external regulatory or customer audits.
• Oversee quality inspection processes to ensure products meet specifications, standards, and release requirements.
• Partner with operations, engineering, and production teams to resolve quality issues and improve manufacturing performance.
• Maintain and improve procedures, records, training, and quality system documentation.

Skills

5+ years exp

Quality leadership

Regulatory knowledge

Root cause analysis

Documentation

Cross-functional leadership

Communication skills

Job description

Design Hire is seeking a Quality Manager to lead quality systems within a regulated manufacturing environment. This role emphasizes improving processes, supporting audits, and maintaining high standards across production and documentation.

Experience in medical device manufacturing and familiarity with FDA audits are strongly valued. The role requires hands-on leadership and collaboration with operations, engineering, and production teams to resolve quality issues and ensure products meet