Quality Manager

Real Staffing; Brooklyn Park (MN); On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

Bonus Eligibility

Comprehensive Benefits

Job summary

Specialist Staffing Group, a growing medical device manufacturing organization in Brooklyn Park, MN, seeks an experienced Quality Manager to lead inspection and quality control operations within a highly regulated environment.

You will oversee Incoming, In-Process, Final Inspection, and Quality Laboratory functions while partnering with Engineering, Operations, and NPI teams to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years in Quality Control or Manufacturing Quality.
• 5+ years of people leadership experience.
• Strong knowledge of FDA 21 CFR 820 and ISO 13485 regulations.
• Experience in regulated manufacturing environments.

Responsibilities

• Lead, coach, and develop Quality Control and Inspection teams.
• Establish and manage KPIs aligned with quality, delivery, safety, and cost.
• Drive a culture of compliance, accountability, continuous improvement, and defect prevention.
• Support workforce planning and resource allocation for production demands and new product launches.
• Ensure inspector training, certification, and qualification requirements are maintained.
• Own inspection processes from requirements definition through validation, release, and change management.
• Standardize inspection methods, sampling plans, and documentation practices.
• Develop robust inspection strategies including visual, dimensional, and functional tests.
• Improve inspection efficiency, repeatability, and reliability while reducing variation and rework.
• Lead initiatives to improve first-pass yield and reduce cost of poor quality.
• Ensure regulatory compliance, customer expectations, and internal procedures.
• Utilize SPC, trend analysis, and risk-based sampling for improvements.
• Support audit readiness and maintain compliant quality documentation and records.
• Collaborate with Design Engineering, Manufacturing, Operations, and Quality teams.
• Support NPI activities and engineering change implementations.
• Communicate quality metrics and improvements to leadership.

Skills

Leadership

Quality Control

Regulatory compliance

Process improvement

Team development

Education

Bachelor's degree in Engineering

Tools

FDA 21 CFR 820

ISO 13485

Job description

Brooklyn Park, Minnesota

Compensation: $100,000 - $160,000 Base Salary + Bonus Eligibility

About the Opportunity

A growing medical device manufacturing organization is seeking an experienced Quality Manager to lead inspection and quality control operations within a highly regulated manufacturing environment. This leadership role is responsible for overseeing Incoming Inspection, In-Process Inspection, Final Inspection, and Quality Laboratory functions while partnering closely with Engineering, Operations, and New Product Introduction teams to ensure product quality, regulatory compliance, and operational excellence.

Key Responsibilities

Leadership & Quality Operations

• Lead, coach, and develop Quality Control and Inspection teams.
• Establish and manage key performance indicators aligned with quality, delivery, safety, and cost objectives.
• Drive a culture of compliance, accountability, continuous improvement, and defect prevention.
• Support workforce planning and resource allocation for production demands and new product launches.
• Ensure inspector training, certification, and qualification requirements are maintained.

Quality Control & Inspection Strategy

• Own inspection processes from requirements definition through validation, release, and controlled change management.
• Standardize inspection methods, sampling plans, and documentation practices.
• Develop and maintain robust inspection strategies including visual, dimensional, functional, and test methods.
• Improve inspection efficiency, repeatability, and reliability while reducing variation and rework.

Continuous Improvement & Compliance

• Lead initiatives to improve first-pass yield and reduce the cost of poor quality.
• Ensure compliance with regulatory requirements, customer expectations, and internal procedures.
• Utilize SPC, trend analysis, and risk-based sampling techniques to drive proactive quality improvements.
• Support audit readiness and maintain compliant quality documentation and records.

Cross-Functional Partnership

• Collaborate with Design Engineering, Manufacturing, Operations, and Quality teams.
• Support New Product Introduction (NPI) activities and engineering change implementation.
• Communicate quality performance metrics, risks, and improvement initiatives to leadership.

Qualifications

Required

• Bachelor's degree in Engineering or a related technical field.
• 5+ years of experience in Quality Control or Manufacturing Quality.
• 5+ years of people leadership experience.
• Strong knowledge of FDA 21 CFR 820 and ISO 13485 regulations.
• Experience working in regulated manufacturing environments.

Preferred

• Lean Manufacturing and/or Six Sigma experience.
• Experience in high-mix manufacturing environments.
• Strong analytical, statistical, and problem-solving skills.

Why Consider This Opportunity?

• Visible leadership role with direct impact on product quality and operational performance.
• Opportunity to drive quality strategy within a growing medical device manufacturing organization.
• Collaborative environment focused on continuous improvement and employee development.
• Competitive compensation package including bonus potential and comprehensive benefits.

Interested candidates with medical device, regulated manufacturing, or advanced manufacturing quality leadership experience are encouraged to apply.

EOE Statement: Specialist Staffing Group 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, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.