Senior Quality Manager - Medical Device & Compliance

Real Staffing Group; 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

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.