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Design Quality Engineer

Posted on: Nov 11, 2026

TekWissen LLC
Warsaw, Indiana
Salary: $44 per hour
Onsite
Full-time

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Job Title :

Design Quality Engineer

Job Type :

Full-Time

Job Location :

Warsaw Indiana United States

Remote :

Job Description :

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.

Job Title: Design Quality Engineer

Location: Warsaw, IN 46580

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Job Summary:

The Design Quality Engineer supports robust and compliant design control practices for sustaining engineering activities.
The role serves as a quality representative on cross-functional teams, supporting compliance with regulatory requirements such as 21 CFR 820, ISO 13485, and EU MDR, as well as internal quality standards.
It also collaborates with Legal, Manufacturing, Operations, and Operations Transfer partners to support compliant development and product/process transitions.
The Design Quality Engineer supports design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle.

Principal Duties and Responsibilities

Support design verification and validation, risk management, and design reviews to help ensure product safety, performance, and regulatory requirements are met.
Review engineering design changes and provide quality input on documentation, traceability, and risk assessment; support continuous improvement of design processes, templates, and procedures
Provide quality support for sustaining engineering projects, product improvements, and Operations Transfer activities, including transfer of products and processes into manufacturing and supplier environments.
Assist with quality deliverables for regulatory submissions, including 510(k), technical documentation, and IDE-related documentation; support audits, quality metrics, management review inputs, and other quality-related duties assigned by management.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Skills:

Expected Areas of Competence (i.e. KSAs)
Working knowledge of ISO 13485, 21 CFR 820, and EU MDR.
Experience with Design Controls and risk management, particularly as related to electronic device design.
Statistical knowledge, including understanding of measurement uncertainty, and experience with statistical analysis and techniques.
Detail-oriented and well organized, with excellent communication skills.
Able to accomplish objectives with general supervision and escalate issues appropriately.
Apply scientific principles and problem-solving, scientific rationale, and technical logic to engineering activities and development decisions.
Evaluate, implement, and validate design changes to existing products; collaborate with Engineering, Legal, Manufacturing, Operations, and Operations Transfer teams to support development workflows and product/process transfers into manufacturing and supplier environments.
Advanced Excel skills, including data analysis and reporting; advanced English communication skills, both written and verbal.

Education:

Expected Areas of Competence (i.e. KSAs)
Working knowledge of ISO 13485, 21 CFR 820, and EU MDR.
Experience with Design Controls and risk management, particularly as related to electronic device design.
Statistical knowledge, including understanding of measurement uncertainty, and experience with statistical analysis and techniques.
Detail-oriented and well organized, with excellent communication skills.
Able to accomplish objectives with general supervision and escalate issues appropriately.
Apply scientific principles and problem-solving, scientific rationale, and technical logic to engineering activities and development decisions.
Evaluate, implement, and validate design changes to existing products; collaborate with Engineering, Legal, Manufacturing, Operations, and Operations Transfer teams to support development workflows and product/process transfers into manufacturing and supplier environments.
Advanced Excel skills, including data analysis and reporting; advanced English communication skills, both written and verbal.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Position Details

Posted:

Nov 11, 2026

Reference Number:

52598-12690

Employment:

Full-time

Salary:

$44 per hour

City:

Warsaw

Job Origin:

CIEPAL_ORGANIC_FEED

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