Quality Manager

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

Job summary

Real in Brooklyn Park, Minnesota is seeking an experienced Quality Manager to lead inspection and quality-control operations in a highly regulated manufacturing environment. This leadership role covers Incoming, In-Process, Final Inspection and the Quality Laboratory, partnering closely with Engineering, Operations, and NPI teams to ensure product quality and regulatory compliance.

The successful candidate will have a Bachelor’s degree in Engineering or a related field, 5+ years in

Qualifications

• Bachelor's degree in Engineering or 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 inspection and quality control teams (incoming, in-process, final, quality lab).
• Develop KPIs aligned with quality, delivery, safety and cost objectives.
• Drive compliance, accountability, continuous improvement and defect prevention.
• Support workforce planning for production demands and new product launches.
• Ensure inspector training, certification and qualification requirements are met.
• Own inspection processes from requirements to release and changes.
• Standardize inspection methods, sampling plans and documentation.
• Develop robust inspection strategies (visual, dimensional, functional, tests).
• Improve efficiency, repeatability, and reduce variation and rework.
• Lead initiatives to improve first-pass yield and reduce cost of poor quality.
• Ensure regulatory compliance and maintain proper documentation.
• Collaborate with Design Engineering, Manufacturing, Operations and Quality.
• Support NPI activities and engineering change implementation.
• Communicate quality metrics, risks, and improvements to leadership.

Skills

Quality leadership

Regulatory knowledge

Manufacturing quality

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical field

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.

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.