Our Client, a Medical Devices / Healthcare company, is looking for a Supplier Quality Engineer I for their Englewood, CO location.
Responsibilities:
Responsible for executing Supplier Production Process Approval (SPPA) remediation activities in support of Quality Management System integration.
Gathers, reviews, and analyzes supplier manufacturing, quality, inspection, and process data to identify gaps and establish appropriate quality controls.
Plans and executes assigned supplier remediation activities against established project timelines and works cross-functionally with Supplier Quality, Manufacturing, Development, Quality, and external suppliers to drive activities through completion.
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 and 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, with the ability to work independently and effectively with cross-functional teams and external suppliers.
Bachelor’s degree in Engineering or an alternative Bachelor’s degree with relevant Quality Engineering experience or certification (e.g., CQE).
Certification as a Quality Engineer (CQE), Reliability Engineer (CRE), or other applicable ASQ certification preferred.
Minimum of 2 years of experience in a Quality Engineering, Supplier Quality, or related role, with medical device experience strongly preferred.
An equivalent combination of education, certification, and relevant experience may be considered.
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
American Society for Quality (ASQ)unmatched
Analysis Skillsunmatched
Certified Quality Engineer (CQE)unmatched
Collocationunmatched
Cross-Functionalunmatched
Data Processingunmatched
Documentationunmatched
Engineeringunmatched
Engineering Drawingunmatched
Geometric Dimensioning and Tolerancingunmatched
Health Planunmatched
Healthcareunmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Manufacturing Analysisunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Validationunmatched
Project Executionunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Reliability Engineeringunmatched
System Integration (SI)unmatched
Systems Analysisunmatched
Tolerance Analysisunmatched
Vendor/Supplier Evaluationunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.