Quality Engineer Job Listing at Kelly Services in Irvine, CA (Job ID US3580395_BH9887626)

Description

Kelly Engineering is seeking a Sr. Quality Engineer for a long-term contract with one of our global medical device clients in Irvine, CA.  
Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders.  Established their leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter.
Join a Leading Innovator in Cardiac Care and Device Development.

The Sr. Quality Engineer plans and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product. 

JOB SUMMARY
     The Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies, Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
     The Sr. Quality Engineer assists sustaining and/or supply chain teams to develop quality-engineered systems and products, and support production floor activities (among which IQ/OQ/PQ, Calibration) and product quality investigations and Corrective and Preventive Actions (CAPAs). The Sr. Quality Engineer will perform release activities related to the manufacturing operations of the site. The Sr. QE will work on complex problems and projects and will demonstrate leadership in driving program/projects and be resourceful and creative in developing approaches and solutions to problems.

DUTIES & RESPONSIBILITIES

• 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 practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Lead and/or review, from a Quality perspective, Non-Conformance and CAPA Investigations.  Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Perform release activities related to the manufacturing operations of the site.
• Develop and establish effective quality control and support associated risk management plans.
• Develop and establish effective quality plans.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, calibrations, and engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Design of Experiments, etc.).
• Ensure that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing.
• Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
• Assist in complaint analysis as appropriate.
• Assist Regulatory Affairs in developing submissions for new devices as necessary.
• Recommend issue resolution to senior management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

• A minimum of four (4) years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required.
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e. Root Cause Problem Solving) is required
• Ability to apply project management skills to ensure fulfillment of new product development requirements is required
• Demonstrated problem-solving skills are required 
• In-depth knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is required.
• Ability to effectively communicate with internal and external personnel at all levels of the organization is required
• Well-developed influencing and negotiation skills are required
• Ability to effectively train a diverse array of employees at all levels of the organization is required
• Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques
• In-depth understanding of Six Sigma and Process Excellence tools and methodologies is preferred
• This position is located in Irvine, California, and may require up to 10% travel domestically.

Required Knowledge:

• Working knowledge of the Regulations and laws as they pertain to Medical Devices
• Practical knowledge of ISO13485.
• Experience in the Medical Device industry or medical field.
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• Knowledge of specific business practices and software and software applications

Required Skills or Abilities:

• Ability to define problems, gather information, plan, and execute objectives.
• Good interpersonal relations
• Good English skills (write/speak)
• Self-confidence and integrity
• Self-motivated and project-oriented, whether independently or with a team
• Good communication skills, both verbal and written
• Strategic thinking, results and performance driven.
• Big picture orientation with attention to detail

Important information: Applicants must be legally permitted to work in the United States immediately and without employer sponsorship
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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 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?

Looking to work with leading project management organizations at top companies around the world? That's where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That's just good planning.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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