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29 days old

Quality Engineer

Kelly Services
Yorba Linda, CA 92886
**Kelly** is currently seeking a **Quality Engineer** in the **Yorba Linda, CA** area for a long-term opportunity with a leading team! In this position, you will be part of Quality Engineering Team working on leading validation of test methods for dental implants and components. You will be responsible for developing metrology and in-process inspection methods for NPI to verify that parts meet the drawing specification and standards. In this position you will work closely with supplier, operation, quality, engineering, manufacturing and management team members.


**ACCOUNTABILITIES**


+ Plans and conducts inspection of equipment validations

+ Interact with other departments to resolve development, manufacturing and/or customer issues

+ Work directly with internal customers to understand measurement request requirements, analyze data, and effectively communicate results

+ Perform high precision dimensional, coordinate, and surface metrology in support of product and process development and manufacturing

+ Ensure effective preventative maintenance and interim performance verification of high precision metrology equipment

+ Execute experiments in support of measurement equipment and measurement process fundamental understanding and uncertainty analyses

+ Analyze experimental and measurement data using sound statistical methods for development of measurement uncertainty analyses, identification of data trends, and root cause analyses

+ Interact with suppliers to align measurement methods and answer technical questions


**KNOWLEDGE, SKILLS & EXPERIENCE**


+ Bachelor's Degree within Engineering capacity, with minimum 3 years of experience within Quality/Regulatory Affairs background or Associates Degree with 5+ years of experience in Engineering role

+ Knowledge of FDA CFR 820 Quality System Regulation requirements (GMP) and ISO 13485 standard

+ Experience conducting root cause investigations

+ English proficiency both in written and oral communications and reading comprehension

+ Proficiency skills in MS Office. SAP and FileMaker experience a plus.

+ Ability to read and interpret blueprints/drawings.

+ Provide technical support during product evaluation/investigation.


**Critical Skills/technical know-how:**


+ Attention to detail


+ Good organization and presentation skills

+ Understanding of regulatory compliance practices

+ Presentation, analytical and creative thinking abilities are required

+ Ability to judge urgency of situations, calls etc., and meet deadlines

+ Cooperation/teamwork


**Critical Experience:**


+ A minimum of 1 year experience working in a regulated/medical device manufacturing environment such as a GMP and/or ISO environment.

+ Experience conducting Product Non-Conformance investigations

+ Knowledge of Excel, Word, and/or other industry software.

+ Ability to handle multiple assignments.


+ Effective interpersonal and problem-solving skills.

+ Quality Oriented / Customer focus Decision making

+ Continuous improvement

+ Must be self-directed, able to work in a fast-paced, growth environment


**CRITICAL SUCCESS FACTORS AND KEY CHALLENGES**


+ Multiple projects/tasks will present challenges in time management while adding complexity in

+ meeting objectives and goals

+ Ability to work closely with internal and external customers around the world to meet their requirements

+ Very strong verbal and written communication skills

+ Strong initiative

+ Self-motivated with ambition for technical growth

+ Accountable for actions/behaviors

+ Ability to work independently

+ Ability to understand and apply organization-level strategies for the success of the business


Apply today for immediate consideration!


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-05-26 Expires: 2021-06-26

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Quality Engineer

Kelly Services
Yorba Linda, CA 92886

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