Senior Quality Engineer, Medical Device: Process Improvement

Regulatory Jobs; Brooklyn Park (MN); Sur place; USD 91 000 - 136 000; Plein temps

Avantages offerts par ce poste

401k with company match

Onsite health clinics

Cretex University

Profit sharing

Paid holidays & PTO

Employee assistance program

Résumé du poste

Cretex Medical is seeking a Quality Engineer III to provide quality assurance support for manufacturing. You will define, implement, and improve quality practices and provide technical guidance and measurement methodologies support.

Responsibilities include quality engineering support, developing inspection requirements, audits, CAPA, and mentoring junior engineers. This role requires ensuring compliance with ISO and medical device quality standards within a fast-paced manufacturing environment.

Qualifications

• Bachelor’s degree in Mechanical, Industrial, or Engineering Science.
• 6 years of engineering experience in machining/manufacturing.
• Knowledge of quality systems and regulatory requirements.
• Advanced blueprint reading and GD&T skills.
• Experience with DOE and Capability Studies.
• Proficiency with ERP systems and MS Office.

Responsabilités

• Provide quality assurance support for manufacturing and projects.
• Develop inspection requirements and control/inspection plans.
• Analyze data and identify improvement opportunities.
• Lead CAPA via root cause analysis and corrective actions.
• Audit planning and closure; report findings and actions.
• Mentor lower-level Quality Engineers and train staff.
• Ensure ISO and medical device quality system compliance.

Connaissances

Quality systems

GD&T

DOE

Data analysis

Communication

ERP systems

MS Office

Formation

Bachelor's degree in Mechanical/Industrial/Engineering

Outils

Minitab

inspection equipment

Description du poste

Cretex Medical is seeking a Quality Engineer III to provide quality assurance support for manufacturing. You will define, implement, and improve quality practices and provide technical guidance and measurement methodologies support.

Responsibilities include quality engineering support, developing inspection requirements, audits, CAPA, and mentoring junior engineers. This role requires ensuring compliance with ISO and medical device quality standards within a fast-paced manufacturing environment.