Quality Engineer

Kelly; Irvine (CA); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Vacation

Sick Time

Holiday Pay

Job summary

Kelly Services (on behalf of Johnson & Johnson) in Irvine, CA is hiring a qualified R&D/Quality Engineer to support development, transfer, and lifecycle management of EP catheters and medical devices. This long term contract role focuses on quality assurance, process validation, risk management, and data-driven improvements.

The candidate will collaborate with R&D, Operations, and external facilities, ensuring compliance with design controls and MDR/GSPR requirements.

Qualifications

• Experience in quality engineering for medical devices.
• Familiarity with quality tools and process validation.
• Ability to analyze data with Six Sigma/DOE methods.

Responsibilities

• Support development and lifecycle management of products.
• Lead quality assurance activities across projects.
• Perform risk analyses (AFMEA, DFMEA, PFMEA) and CAPA actions.
• Develop and implement QC plans and validation protocols.
• Utilize statistics (DOE, SPC) to improve processes.

Skills

Quality tools

Six Sigma

SPC

DOE

Design of Experiments

Tools

Process validation

Equipment qualification

Job description

As an Quality Engineer you will play a key role in developing and assembling innovative electrophysiology (EP) catheters and medical devices used in the diagnosis and treatment of heart rhythm disorders.

Job Responsibilities/ Requirements

Kelly Services, the leader in Manufacturing Career Placement is proud to announce we are now partnering with Johnson & Johnson located in Irvine, CA. Johnson & Johnson is rapidly expanding and is immediately hiring a qualified R&D Technician to support production demand and new product development. This is a long term contract role.

Position Summary

Johnson & Johnson is a global leader in cardiac electrophysiology, providing advanced catheter technology that helps physicians accurately map and treat arrhythmias, including atrial fibrillation.

Benefits

• Medical
• Dental
• Vision
• 401K
• Vacation
• Sick Time
• Holiday Pay

Location: Irvine, CA

Job Responsibilities/ Requirements

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practicesfor the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts for continuous quality and customer satisfaction improvement opportunities.
• Support Non-Conformance Report (NCR) process for Client facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Assigns/reviews quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed (e.g., review of work orders, support cleanroom activities, etc.)

Important information

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly?

• As a Kelly Services employee, you will have access to numerous perks, including:Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.