Senior Quality Engineer – Medical Devices (Onsite)

Real; Fridley (MN); On-site; USD 100,000 - 117,000; Full time

Benefits offered by this job

Bonus opportunity

Comprehensive health benefits

401(k) with company match

Paid time off

Professional development and tuition

tuition assistance

Job summary

Specialist Staffing Group is seeking a Quality Engineer III for an established healthcare manufacturing client in the Twin Cities Metro Area. The role partners with engineering, operations, and customers to ensure products and processes meet quality, regulatory, and customer requirements onsite.

You will lead quality activities for new product and process development, support validation, SPC/DOE, CAPA, and root cause analysis, and mentor teammates while maintaining compliance with ISO standards

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years of quality engineering experience in a regulated manufacturing environment.
• Experience with process validation, root cause analysis, SPC, DOE, CAPA, and quality systems.
• Knowledge of ISO 13485, ISO 9001, or similar quality standards preferred.
• Proficiency with statistical analysis tools and ERP/MRP systems.
• Strong problem-solving, communication, and project management skills.
• ASQ CQE certification and medical device experience are a plus.

Responsibilities

• Lead quality activities for new product and process development projects.
• Support validation, process characterization, statistical analysis, and inspection planning.
• Investigate nonconformances, perform root cause analysis, and implement corrective actions.
• Analyze product and process performance using statistical tools and quality metrics.
• Support customer complaints, audits, and continuous improvement initiatives.
• Collaborate cross-functionally to maintain compliance with quality system requirements.
• Provide technical guidance and mentorship to team members.

Skills

Root cause analysis

Statistical analysis

Problem solving

Project management

Communication

Quality systems knowledge

CAPA

DOE

SPC

ISO 13485 / ISO 9001 knowledge

ASQ CQE certification

Education

Bachelor's degree in Engineering or related technical field

Tools

ERP/MRP systems

Job description

Specialist Staffing Group is seeking a Quality Engineer III for an established healthcare manufacturing client in the Twin Cities Metro Area. The role partners with engineering, operations, and customers to ensure products and processes meet quality, regulatory, and customer requirements onsite.

You will lead quality activities for new product and process development, support validation, SPC/DOE, CAPA, and root cause analysis, and mentor teammates while maintaining compliance with ISO standards