What are the responsibilities and job description for the Quality Systems Manager position at IntePros?
Direct Hire
Onsite
North Metro Minneapolis, MN
Quality Systems Manager Position Summary
The Quality Systems Manager is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, and other global standards). Key responsibilities include managing Document Control and CAPA functions, ensuring robust governance, timely execution, and effectiveness of quality system processes. The role partners cross-functionally with Operations, Engineering, and Supply Chain to embed quality into all stages of the product lifecycle and to support audit readiness and inspection success.
Responsibilities
Audit Leadership & Regulatory Readiness
Provide leadership oversight to second- and third-party audits, including preparation, execution, reporting, and closure of audit findings. Ensure sustained inspection of readiness and successful outcomes with regulatory bodies and customers.
Internal Audit Program Management
Provide leadership oversight the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions to strengthen the QMS.
QMS Compliance & Continuous Improvement
Develop, maintain, and continuously improve a robust Quality Management System compliant with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations, ensuring scalability with organizational growth.
CAPA & Complaint Management Oversight
Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs, including root cause analysis, corrective/preventive actions, effectiveness checks, and trend analysis.
Process & Product Quality Improvement
Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk-based methodologies.
Regulatory & Customer Interface
Provide leadership in regulatory matters and serve as a key quality representative to customers, ensuring alignment with regulatory requirements and customer expectations.
Global QMS Strategy & Standardization
Establish and maintain a global QMS framework that supports multi-site operations, harmonization, and future growth, including acquisitions and integration efforts.
Supplier Quality Integration
Represent Quality on the Supplier Qualification Team & supplier performance reviews, ensure that Approved Supplier List (ASL), and supplier audits meets regulatory standards.
Training & Quality Culture Development
Develop and sustain QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement.
Cross-Functional Collaboration
Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality.
Digital QMS Systems Management
Implement, maintain, and optimize Global QMS software, ensuring system effectiveness, data integrity, and user adoption.
Management Review & Metrics
Support preparation and presentation of Management Review inputs, ensuring clear visibility to QMS performance, risks, and improvement opportunities.
Team Leadership & Development
Lead, coach, and mentor the QMS team, fostering a high-performing organization with strong accountability, engagement, and capability development.
Qualifications
Quality Systems Manager Requirements:
Bachelor’s degree or 6 years of equivalent work experience
5 years of experience managing quality management systems
Experience with ISO 13485:2016 and FDA
Lead Auditor Certification
Ability to consistently achieve short and long-term business results
Ability to prioritize work and manage multiple tasks when needed
Ability to follow through on commitments and hold team members accountable
Consistently produces work that meets the customer’s requirements
Project management skills
Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
Clear and effective verbal and written communication skills
Attention to detail
Organizational skills
Ability to work in a fast-paced team environment
Ability to prioritize and multitask
Quality Systems Manager Preferred Requirements
Quality systems experience in a manufacturing setting
Continuing education; including participation in local chapters, associations, and/or organizations
Pay Range
USD $100,000.00 - USD $150,000 /Yr.
Pay Range Details
This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.
Compensation
Company Benefits
This is a bonus eligible position.
All Employees
Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Clients University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all employees.
Onsite
North Metro Minneapolis, MN
Quality Systems Manager Position Summary
The Quality Systems Manager is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, and other global standards). Key responsibilities include managing Document Control and CAPA functions, ensuring robust governance, timely execution, and effectiveness of quality system processes. The role partners cross-functionally with Operations, Engineering, and Supply Chain to embed quality into all stages of the product lifecycle and to support audit readiness and inspection success.
Responsibilities
Audit Leadership & Regulatory Readiness
Provide leadership oversight to second- and third-party audits, including preparation, execution, reporting, and closure of audit findings. Ensure sustained inspection of readiness and successful outcomes with regulatory bodies and customers.
Internal Audit Program Management
Provide leadership oversight the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions to strengthen the QMS.
QMS Compliance & Continuous Improvement
Develop, maintain, and continuously improve a robust Quality Management System compliant with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations, ensuring scalability with organizational growth.
CAPA & Complaint Management Oversight
Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs, including root cause analysis, corrective/preventive actions, effectiveness checks, and trend analysis.
Process & Product Quality Improvement
Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk-based methodologies.
Regulatory & Customer Interface
Provide leadership in regulatory matters and serve as a key quality representative to customers, ensuring alignment with regulatory requirements and customer expectations.
Global QMS Strategy & Standardization
Establish and maintain a global QMS framework that supports multi-site operations, harmonization, and future growth, including acquisitions and integration efforts.
Supplier Quality Integration
Represent Quality on the Supplier Qualification Team & supplier performance reviews, ensure that Approved Supplier List (ASL), and supplier audits meets regulatory standards.
Training & Quality Culture Development
Develop and sustain QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement.
Cross-Functional Collaboration
Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality.
Digital QMS Systems Management
Implement, maintain, and optimize Global QMS software, ensuring system effectiveness, data integrity, and user adoption.
Management Review & Metrics
Support preparation and presentation of Management Review inputs, ensuring clear visibility to QMS performance, risks, and improvement opportunities.
Team Leadership & Development
Lead, coach, and mentor the QMS team, fostering a high-performing organization with strong accountability, engagement, and capability development.
Qualifications
Quality Systems Manager Requirements:
Bachelor’s degree or 6 years of equivalent work experience
5 years of experience managing quality management systems
Experience with ISO 13485:2016 and FDA
Lead Auditor Certification
Ability to consistently achieve short and long-term business results
Ability to prioritize work and manage multiple tasks when needed
Ability to follow through on commitments and hold team members accountable
Consistently produces work that meets the customer’s requirements
Project management skills
Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
Clear and effective verbal and written communication skills
Attention to detail
Organizational skills
Ability to work in a fast-paced team environment
Ability to prioritize and multitask
Quality Systems Manager Preferred Requirements
Quality systems experience in a manufacturing setting
Continuing education; including participation in local chapters, associations, and/or organizations
Pay Range
USD $100,000.00 - USD $150,000 /Yr.
Pay Range Details
This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.
Compensation
Company Benefits
This is a bonus eligible position.
All Employees
Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Clients University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all employees.
Salary : $100,000 - $150,000