Quality Manager

Caerus Corp; Blaine (MN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, dental, vision, basic life, AD

401(k) retirement plan with employer 0

Paid time off and holidays

Tuition Assistance Program

Employee Brace Program

Job summary

Caerus Corp in Blaine, MN is seeking a Quality Manager to lead the QMS for Class II medical devices and customer products, ensuring compliance with FDA/ISO standards and driving continuous improvement.

The role involves CAPA execution, complaint handling, audits, and risk-based decision making, with hands-on leadership across quality, operations, and engineering.

Join a collaborative team committed to quality, with comprehensive benefits and opportunities to own and shape quality processes.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 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 ISO 13485 requirements.
• Direct experience leading CAPA, complaint handling, nonconformance, and audit processes.
• Ability to apply root cause analysis and risk-based thinking to complex quality issues; cross-functional collaboration.

Responsibilities

• Provide leadership and 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.

Skills

CAPA leadership

Root cause analysis

Risk-based thinking

Regulatory compliance

Cross-functional collaboration

Quality systems

Audits

Communication skills

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related field

Job description

Job Details

Job Location: Corporate HeadQuarters - Blaine, MN 55449

Position Type: Full Time

Education Level: 4 Year Degree

Salary Range: $90,000.00 - $130,000.00 Salary/year

Travel Percentage: Up to 25%

Job Category: Manufacturing

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 & 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.

Qualifications

Minimum Qualifications:

• 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.

What Sets You Apart

• 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.

Compensation

Caerus Corp provides the following information about compensation for this position:

• Salary Range: $90,000– $130,000per year.

The salary range is based on several factors which will vary based on position. These include labor markets and, in some instances, may include but not limited to education, work experience, scope and responsibilities of position and geographic location.

Benefits:

• Health, dental, vision, basic life, and AD&D insurance
• 401(k) retirement plan with employer match
• Paid time off (Vacation and Protected paid time) and 6 company designated holidays
• Tuition Assistance Program
• Employee Brace Program

Employment Eligibility / E-Verify

Caerus Corp participates in the federal E-Verify program to confirm the employment eligibility of all newly hired employees. Employment eligibility will be verified after hire through completion of Form I-9 and the E-Verify process, as required by law.

Equal Opportunity Employer

CaerusCorp is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by applicable federal, state, or local law.

Reasonable Accommodation

The Company is committed to providing reasonable accommodation to qualified individuals with disabilities. If you require assistance or accommodation during the application process, please [e-mail].

Caerus Corp., headquartered in Blaine, MN is a developer, manufacturer, and marketer of innovative Class II medical devices, medical devices and soft goods. Our brands include: OrthoCor Medical, Red Fox Innovations and New Options Sports.