Quality Engineer

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering/Technology – Project Services?

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About Kelly

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.