Senior Quality Engineer – Medical Devices QA

Cretex Companies, Inc.; BLOOMINGTON (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

QTS in Bloomington, MN is seeking a Senior Quality Engineer to provide quality assurance support for manufacturing. This full-time role focuses on defining and improving quality practices and offering technical guidance.

You will act as customer-facing quality representative on development projects, handle complaints, and drive corrective and preventive actions, with responsibility for inspection methods, PFMEAs, and quality documentation.

Responsibilities

• 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

Job description

QTS in Bloomington, MN is seeking a Senior Quality Engineer to provide quality assurance support for manufacturing. This full-time role focuses on defining and improving quality practices and offering technical guidance.

You will act as customer-facing quality representative on development projects, handle complaints, and drive corrective and preventive actions, with responsibility for inspection methods, PFMEAs, and quality documentation.