Quality Manager, Medical Device Ops & Compliance

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

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