Sr. Quality Engineer

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

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Responsibilities

Senior Quality Engineer Ideal Candidate Profile

QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Quality Engineer who will be responsible for providing quality assurance support for manufacturing. This position will also be responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Senior Quality Engineer Job Summary

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