Supplier Quality Engineer I

TekWissen•Englewood, CO

2d•Onsite

About The Position

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.

Requirements

Strong knowledge of supplier quality, process validation, process capability, measurement system analysis, and inspection controls.
Experience evaluating manufacturing processes and quality data, including process capability studies and Gage R&R.
Ability to interpret engineering drawings, specifications, tolerances, CTQs, and GD&T.
Ability to translate technical requirements into appropriate process and inspection controls.
Working knowledge of applicable ISO and QSR/QMSR requirements.
Demonstrated ability to identify quality and documentation gaps, develop appropriate solutions, and drive remediation activities through closure.
Strong analytical, problem-solving, communication, and project execution skills.
Ability to work independently and effectively with cross-functional teams and external suppliers.
Minimum of 2 years of experience in a Quality Engineering, Supplier Quality, or related role.

Nice To Haves

Medical device industry experience strongly preferred.
Certified Quality Engineer (CQE).
Certified Reliability Engineer (CRE).
Other applicable ASQ certifications.

Responsibilities

Execute Supplier Production Process Approval (SPPA) remediation initiatives.
Analyze supplier manufacturing and quality documentation.
Identify process, quality, and compliance gaps.
Establish and implement appropriate quality controls.
Coordinate supplier quality remediation activities.
Partner with internal and external stakeholders to ensure timely project completion.
Review process capability studies and measurement system analyses.
Support Quality Management System integration activities.
Drive corrective actions and continuous improvement initiatives.
Ensure supplier compliance with internal and regulatory quality requirements.