Quality Engineer II - Medical Device QA & Process Improvement

Regulatory Jobs; Minnesota; On-site; USD 75,000 - 136,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus

Job summary

Cretex Medical seeks a Quality Engineer II/III to provide QA support for manufacturing, shaping quality practices, and guiding measurement methodologies. The role covers audits, PFMEAs, CAPA, data analysis, and interface with production teams to resolve issues and ensure regulatory compliance.

The candidate will work within a medical device-focused environment, collaborating with engineering, sales, and finance, and contributing to continuous improvement initiatives.

Qualifications

• Bachelor’s degree in mechanical/industrial engineering.
• Quality Engineer II: 3+ years in engineering in a machining/manufacturing setting.
• Quality Engineer III: 6+ years in engineering in a machining/manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Intermediate knowledge of blueprint reading and GD&T.
• Ability to analyze data and ensure data integrity.
• Ability to operate a variety of inspection equipment.
• DOE and Capability Studies skills; proficiency with Minitab.
• Strong communication and teamwork; detail orientation.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues; create and maintain control/inspection plans.
• Analyze data and identify improvement opportunities.
• Act as the quality interface for production; respond to customer complaints using FMEA, CAPA, and trend analysis.
• Conduct audits; close out findings; determine corrective and preventive actions.
• Lead and participate in projects; support validation of processes, equipment, and metrology.
• Create protocols and analyze data; ensure compliance with customer requirements and quality systems.

Skills

Quality systems knowledge

Regulatory knowledge

Data analysis

Communication skills

Attention to detail

Team collaboration

Education

Bachelor's Degree in Mechanical, Industrial, or in other EngineeringScience

Tools

Minitab

Microsoft Office

Job description

Cretex Medical seeks a Quality Engineer II/III to provide QA support for manufacturing, shaping quality practices, and guiding measurement methodologies. The role covers audits, PFMEAs, CAPA, data analysis, and interface with production teams to resolve issues and ensure regulatory compliance.

The candidate will work within a medical device-focused environment, collaborating with engineering, sales, and finance, and contributing to continuous improvement initiatives.