Quality Manager

CAERUS CORP•Blaine, MN

12d•Onsite

About The Position

The Quality Manager provides leadership and functional ownership of the Quality Management System (QMS) within a regulated manufacturing environment. This role is responsible for manufacturing and quality operations of Class II medical devices and customer products, ensuring compliance with applicable regulatory requirements, driving continuous improvement, and safeguarding product quality and customer satisfaction. This is a hands-on role requiring direct involvement in CAPA execution, complaint resolution, audit preparation, and quality activities. The position exercises independent judgment and discretion in interpreting quality data, assessing risk, and determining appropriate corrective and preventive actions.

Requirements

Bachelor’s degree in Engineering, Quality, Life Sciences, or related field (or equivalent experience).
5+ years of progressive quality experience in a regulated manufacturing environment (medical devices strongly preferred).
Strong working knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirements.
Direct experience leading CAPA, complaint handling, nonconformance, and audit processes.
Demonstrated ability to apply root cause analysis and risk-based thinking to complex quality issues.
Proven experience working cross-functionally with engineering, operations, and leadership teams.
Experience participating in or leading internal and external regulatory audits
Ability to analyze quality trends and drive systemic improvements.
Strong communication skills with the ability to influence across functions.

Nice To Haves

You take a hands-on approach, take ownership of quality systems and drive issues through resolution.
You are comfortable making decisions in a regulated, fast-paced manufacturing environment.
You can balance compliance requirements with practical operational execution.
You thrive in cross-functional environments and influence outcomes across teams.
You focus on long-term system improvement, not just short-term fixes.

Responsibilities

Provide leadership and functional ownership of the Quality Management System (QMS) within a regulated manufacturing environment, ensuring compliance with FDA, ISO 13485, and other applicable regulatory requirements.
Maintain organizational readiness for internal and external regulatory audits and ensure sustained compliance posture, including representation during audits and leadership of audit response and closure activities.
Lead the development, implementation, and continuous improvement of quality systems, processes, and standards to ensure operational effectiveness and regulatory compliance.
Partner with operations and engineering leadership to resolve complex production quality issues and implement sustainable corrective actions.
Own and govern the end-to-end quality system for CAPA and complaints, including prioritization, investigation strategy, root cause analysis, corrective action effectiveness, and closure oversight.
Analyze quality data, trends, and systemic issues to drive risk-based decision-making and preventive actions.
Provide oversight of supplier quality performance, including escalation and corrective action requirements.
Evaluate nonconforming material trends and determine appropriate disposition decisions based on risk and business impact.
Provide quality oversight for new product introductions and process changes to ensure compliance and risk mitigation.
Collaborate with engineering, manufacturing, and leadership teams to evaluate quality risks and drive resolution strategies.
Lead, develop, and support quality personnel by establishing expectations, priorities, and performance standards.
Ensure effective execution of quality system requirements across the team and promote accountability and capability development.
Align team activities with organizational quality objectives and continuous improvement initiatives.