Quality Engineer

Kelly Services; Monument (CO); On-site; USD 80,000 - 110,000; Full time

Job summary

Kelly Services seeking a detail-oriented Quality Engineer to support product quality, manufacturing excellence, and continuous improvement in a regulated industry. This role will work cross-functionally with Engineering, Manufacturing, Operations, and suppliers to ensure products and processes meet customer, regulatory, and internal requirements.

The ideal candidate has experience supporting New Product Introduction (NPI), developing and maintaining quality documentation, participating in DFMEA

Qualifications

• Bachelor’s degree as required or related technical field.
• Experience in a regulated industry (medical device, aerospace, etc.).
• Experience supporting manufacturing processes and product-quality requirements.
• Knowledge of NPI/product launch, DFMEA/PFMEA, GD&T, root-cause analysis, inspection planning, and quality documentation.
• Strong analytical, communication, documentation, and problem-solving skills.

Responsibilities

• Support quality activities across the product lifecycle from concept to production.
• Participate in NPI activities including design reviews, process development, qualification, validation, and launch.
• Review drawings, specifications, and requirements for quality and manufacturability.
• Apply GD&T to evaluate dimensions and inspection methods.
• Participate in DFMEA, PFMEA, control plans, and risk management.
• Develop and maintain inspection plans, work instructions, and quality records.
• Assist with root-cause analysis and CAPA using structured problem solving.
• Support nonconformance investigations and disposition processes.
• Collaborate to improve process capability, yield, and first-pass quality.
• Support supplier quality activities: evaluations and corrective actions.
• Analyze quality data and use statistics to identify trends.
• Assist with audits (internal, customer, regulatory).
• Ensure compliance with quality-system requirements and standards.
• Help define inspection methods; experience with gage design or gage R&R is a plus.

Skills

Quality engineering

Regulated industry experience

Cross-functional collaboration

Root-cause analysis

Statistical analysis

Documentation

Problem-solving

Process improvement

Education

Bachelor’s degree in Quality Engineering, Mechanical Engineering, Manufacturing Engineering, or related field

Tools

Gage design

Gage R&R

CAD tools

Model-based definition

Job description

Position Summary

We are seeking a detail-oriented Quality Engineer to support product quality, manufacturing excellence, and continuous improvement in a regulated industry. This role will work cross-functionally with Engineering, Manufacturing, Operations, and suppliers to ensure products and processes meet customer, regulatory, and internal requirements.

The ideal candidate has experience supporting New Product Introduction (NPI), developing and maintaining quality documentation, participating in Design Failure Mode and Effects Analysis (DFMEA) activities, and applying Geometric Dimensioning and Tolerancing (GD&T) principles. Experience with gage design is a plus.

Key Responsibilities

• Support quality activities throughout the product lifecycle, from concept and design through production and sustaining engineering.
  
• Participate in and support NPI activities, including design reviews, process development, qualification, validation, and production launch.
  
• Review engineering drawings, specifications, and product requirements for quality and manufacturability.
  
• Apply GD&T principles to evaluate dimensional requirements, inspection methods, and product acceptance criteria.
  
• Participate in DFMEA, PFMEA, control plan, and risk‑management activities.
  
• Develop and maintain inspection plans, work instructions, quality records, and other controlled documentation.
  
• Assist with root‑cause analysis and corrective and preventive actions using structured problem‑solving methods.
  
• Support nonconformance investigations, material review activities, and disposition processes.
  
• Collaborate with Manufacturing Engineering and Operations to improve process capability, yield, and first-pass quality.
  
• Support supplier quality activities, including supplier evaluations, corrective actions, and incoming inspection requirements.
  
• Analyze quality data and use statistical methods to identify trends and improvement opportunities.
  
• Assist with internal, customer, and regulatory audits.
  
• Ensure compliance with applicable quality‑system requirements, company procedures, and regulatory standards.
  
• Help define inspection methods and measurement strategies; experience with gage design or gage R&R is a plus.

Required Qualifications

• Bachelor’s degree in Quality Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical field.
  
• Experience in quality engineering within a regulated industry, such as medical device, aerospace, defense, automotive, or other highly controlled manufacturing environments.
  
• Experience supporting manufacturing processes and product-quality requirements.
  
• Working knowledge of:
  
  • NPI and product launch processes
    
  • DFMEA and PFMEA
    
  • GD&T and engineering drawing interpretation
    
  • Root‑cause analysis and corrective action
    
  • Inspection planning and quality documentation
    
  • Statistical process control and basic quality metrics
    
• Strong analytical, communication, documentation, and problem‑solving skills.
  
• Ability to work effectively with cross‑functional teams and manage multiple priorities.

Preferred Qualifications

• Experience with gage design, measurement‑system analysis, and gage R&R.
  
• Experience with process validation, IQ/OQ/PQ, PPAP, APQP, or similar regulated‑industry launch processes.
  
• Familiarity with ISO 9001, AS9100, ISO 13485, FDA QSR, or other applicable quality‑system standards.
  
• Certified Quality Engineer, Lean, Six Sigma, or similar certification.
  
• Experience with quality‑management systems, ERP systems, and statistical or inspection software.
  
• Experience with CAD tools or model‑based definition.

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