Quality Manager — Lead Medical Device QA Team (On-Site)

QTS Medical Device Outsourcing; BLOOMINGTON (MN); On-site; USD 97,900 - 146,900; Full time

Job summary

A prominent medical device company in Bloomington, Minnesota is seeking a Quality Manager responsible for leading the quality department and ensuring compliance with FDA and ISO standards. The ideal candidate will have over 8 years of experience in quality or engineering within a regulated manufacturing environment. This role involves establishing effective quality policies, overseeing quality communications, and ensuring continual improvement of quality processes. The position is full-time and on-site, situated at a company that values quality and team culture.

Qualifications

• 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field.
• 3 years of leadership experience.
• In-depth knowledge of FDA Quality System Regulation and ISO standards.

Responsibilities

• Build and manage the quality department staff for effective operations.
• Ensure products meet quality management system requirements.
• Monitor QMS processes for compliance and effectiveness.

Skills

Quality Management Systems

Regulatory Compliance

Leadership

Root Cause Analysis

Lean Manufacturing

Education

Bachelor's degree in Engineering, Sciences, Quality

Job description

A prominent medical device company in Bloomington, Minnesota is seeking a Quality Manager responsible for leading the quality department and ensuring compliance with FDA and ISO standards. The ideal candidate will have over 8 years of experience in quality or engineering within a regulated manufacturing environment. This role involves establishing effective quality policies, overseeing quality communications, and ensuring continual improvement of quality processes. The position is full-time and on-site, situated at a company that values quality and team culture.