Senior Quality Engineer – Medical Device QA & Compliance

Quality Tech Services, LLC; BLOOMINGTON (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Quality Tech Services, LLC (QTS) is seeking a Senior Quality Engineer to provide QA support for manufacturing and to lead the definition, implementation, and improvement of quality practices. The role includes acting as a technical guide and interface for the production team to address customer feedback, complaints, and quality issues.

The ideal candidate will develop inspection methods, participate in PFMEA/MSA activities, and support both internal and external audits, ensuring corrective and

Qualifications

• Senior Quality Engineer with manufacturing QA experience.
• Develop and improve quality practices and guidance.
• Respond to customer complaints using failure analysis and corrective actions.

Responsibilities

• Customer facing quality representative for development projects, complaints, and customer feedback.
• Develop and execute inspection methods; TMV/MSA protocols and reports; facilitate PFMEAs; resolve discrepant material issues and maintain quality documents and plans.
• Act as the quality interface for the production team in responding to customer complaints using failure analysis and corrective/preventive actions.
• Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings and determining proper corrective and preventive actions.

Skills

Quality Assurance

PFMEA

MSA

Audits

Documentation

Job description

Quality Tech Services, LLC (QTS) is seeking a Senior Quality Engineer to provide QA support for manufacturing and to lead the definition, implementation, and improvement of quality practices. The role includes acting as a technical guide and interface for the production team to address customer feedback, complaints, and quality issues.

The ideal candidate will develop inspection methods, participate in PFMEA/MSA activities, and support both internal and external audits, ensuring corrective and