HiringCafe
Posted 2d ago

Quality Manager

@ Caerus Corp
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Blaine, Minnesota, United States
$90k-$130k/yrOnsiteFull Time
Responsibilities:Lead quality management system, Maintain audit readiness, Drive CAPA and corrective actions
Requirements Summary:Bachelor’s degree in Engineering, Quality, Life Sciences, or related field; 5+ years regulated manufacturing quality experience (medical devices preferred); knowledge of FDA 21 CFR Part 820 and ISO 13485; lead CAPA/complaint/nonconformance/audit processes; root cause analysis and risk-based thinking; cross-functional collaboration; participate in regulatory audits.
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Job Description

Why Join Us?  

We’re a mid-sized medical device and contract manufacturer, which means you get the best of both worlds: meaningful work in a regulated environment without the layers of bureaucracy you’ll find at larger organizations.  

Here, your ideas don’t get lost in an approval chain. Team members are encouraged to provide feedback, share suggestions, and directly see the impact of their work on processes, products, and outcomes. What you contribute matters, and you can see it come to life.  

Because we’re always growing and evolving, there is a strong opportunity for individuals who enjoy building, improving, and solving problems. If you’re someone who is comfortable rolling up your sleeves, taking ownership, and helping shape how things are done, you’ll thrive here.  

We do best with people who are curious, hands-on, and motivated to learn and grow. In return, you’ll gain exposure across functions, develop new skills quickly, and have a direct role in improving how we operate.  

Position Summary: 

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.    

Duties and 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.