Senior Quality Engineer - Injection Molding | Medical Devices | US-Based Only

Straffing AI; Brooklyn Park (MN); On-site; USD 91,000 - 130,000; Full time

Job summary

Strafing AI in Brooklyn Park, MN is seeking a Senior Quality Engineer to drive manufacturing quality in a highly regulated medical-device environment. This hands-on role covers production support, process improvement, validation, inspection, CAPA, and quality systems.

You will lead PFMEA, control plans, audits, and mentor junior engineers, collaborating with Manufacturing, Engineering, and Quality teams. Experience in injection molding and ISO 13485 / FDA-regulated settings is highly valued;

Qualifications

• We are seeking candidates with hands-on quality engineering in manufacturing environments.
• Strong knowledge of PFMEA, CAPA, root-cause analysis, and statistical methods.
• Experience with metrology, inspection plans, and quality documentation is essential.

Responsibilities

• Provide quality engineering support to manufacturing and cross-functional project teams.
• Develop and maintain inspection plans, control plans, quality documentation, and manufacturing quality requirements.
• Facilitate PFMEA activities and manufacturing risk assessments.
• Investigate nonconforming material and drive CAPA and trend analysis.
• Support customer complaint investigations, root-cause analysis, and audit closures.
• Apply DOE, SPC, and data analysis to identify process improvements.
• Support validation activities for processes, equipment, and metrology.

Skills

PFMEA

CAPA

DOE

SPC

Root-cause analysis

Data analysis

Education

Bachelor’s in Mechanical Engineering

Tools

Minitab

ERP systems

Job description

Compensation: $91,000 - $130,000 annually

Experience: 6+ years

We are seeking an experienced Senior Quality Engineer to support manufacturing quality within a precision medical-device manufacturing environment.

This is a hands-on quality engineering role supporting production, process improvement, validation, inspection, corrective actions, and quality systems. Candidates with experience in injection molding, medical-device manufacturing, precision manufacturing, or other highly regulated manufacturing environments will be particularly relevant.

Key Responsibilities

Location: Brooklyn Park, MN

Work Arrangement: On-site

Compensation: $91,000 - $130,000 annually

Experience: 6+ years

Relocation Assistance: Not available

Visa Sponsorship: Not available

We are seeking an experienced Senior Quality Engineer to support manufacturing quality within a precision medical-device manufacturing environment.

This is a hands-on quality engineering role supporting production, process improvement, validation, inspection, corrective actions, and quality systems. Candidates with experience in injection molding, medical-device manufacturing, precision manufacturing, or other highly regulated manufacturing environments will be particularly relevant.

Key Responsibilities

• Provide quality engineering support to manufacturing and cross-functional project teams.
• Develop and maintain inspection plans, control plans, quality documentation, and manufacturing quality requirements.
• Facilitate and support PFMEA activities and manufacturing risk assessments.
• Investigate nonconforming or discrepant material and drive appropriate corrective and preventive actions.
• Support customer complaint investigations through failure analysis, root-cause analysis, CAPA, and trend analysis.
• Analyze manufacturing and quality data to identify process-improvement opportunities.
• Support process, equipment, and metrology validation activities.
• Develop validation protocols and analyze validation and manufacturing data.
• Perform and support internal and external quality audits and ensure closure of audit findings.
• Provide technical guidance related to inspection methodologies, measurement systems, and quality requirements.
• Support Quality Inspectors in ensuring inspection plans meet product and customer requirements.
• Apply statistical quality techniques including DOE, process capability studies, SPC, and data analysis.
• Support implementation and maintenance of quality-management and business systems.
• Partner with Manufacturing, Engineering, Operations, Customer Service, Sales, and other functions.
• Mentor and provide technical guidance to less-experienced quality engineers when required.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or another relevant engineering discipline.
• Minimum 6 years of engineering or quality-engineering experience within a manufacturing environment.
• Strong experience with manufacturing quality systems, regulatory requirements, and industry standards.
• Advanced knowledge of blueprint reading and GD&T.
• Hands-on experience with inspection equipment, metrology, and dimensional inspection methodologies.
• Experience with PFMEA, CAPA, nonconformance investigations, root-cause analysis, control plans, and inspection plans.
• Strong statistical quality background, including DOE and capability studies.
• Working experience with Minitab or equivalent statistical analysis tools.
• Experience supporting process and/or equipment validation.
• Experience using ERP and quality-management systems.
• Strong analytical, organizational, communication, and problem-solving skills.
• Ability to work effectively in a fast-paced manufacturing environment.
  

Highly Preferred

• Experience supporting injection molding or plastics manufacturing processes.
• Experience within the medical-device industry.
• Experience working within ISO 13485, FDA-regulated, or similarly controlled manufacturing environments.
• Experience with IQ/OQ/PQ or other formal process-validation methodologies.
  

Important Eligibility Requirements

This is a fully onsite position in Brooklyn Park, Minnesota.

Candidates must be able to work onsite without relocation assistance.

Applicants must already be legally authorized to work in the United States for any employer. Visa sponsorship is NOT available now or in the future.