Description
Kelly Science, Engineering, Technology, and Telecom, a managed solution provider and business unit of Kelly Services, is seeking a Quality Engineer for a long-term contract at one of our Global Medical Device Robotics & Digital Solutions clients in Santa Clara, CA. A global leader in surgery with products and solutions found in almost every operating room around the world.
As the Quality Engineer you will be responsible for providing quality engineering support for manufacturing.
This role is a full-time, fully benefited contract. As a Kelly employee in this group you will be eligible for 50% paid Medical & Dental, a 401K plan, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All KellyOCG employees receive annual performance reviews.
Our client is a Robotics & Digital Solutions company and is part of a global leader in surgery with products and solutions found in almost every operating room around the world. They have made significant contributions to surgery for more than 100 years from creating the first sutures to revolutionizing surgery with minimally invasive procedures. Their continuing dedication to Shaping the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues and improve and save more lives. Through their surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars, and hemostats, and our commitment to treating serious medical conditions like obesity and cancer worldwide, they deliver innovation to make a life-changing impact.
Established and productive individual contributor in a scientific/technology field. Creates, under general supervision, Quality Engineering schematics, detailed layouts, and subsequent comprehensive supply chain outputs, as well as associated key performance metrics, goals, and objectives. Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables.
The Quality Engineer will be responsible for providing quality engineering support for manufacturing. The ideal candidate should have experience supporting complex electro-mechanical, software-controlled systems for medical applications. This individual will work with engineering teams within the company. This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485). Candidates should also have knowledge and experience to support qualifications and manufacturing/testing requirements like TMV and protocol development, and risk management per FDA, ISO 14971, and other applicable medical devices standards.
Job Description
• Identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives to ensure deliverables are aligned with customers' operational needs and requirements.
• Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Examines capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
• Performs process validations (IQ/OQ/PQ or TMVs) on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
• Will be responsible for creating or actively supporting risk analyses and FMEA's.
• Facilitates supervision of Quality Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements.
• Communicates and escalates in a timely manner, any Quality Engineering issues, or concerns to the next management level.
• Coach more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies companies credo and Leadership Imperatives in day-to-day interactions with team.
• While performing the duties of this job, the employee is regularly required to attend meetings, observe in labs or the manufacturing area. The employee frequently is required to sit, stand, or walk.
• This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:00 a.m. to 5:00 p.m.
• Occasional evening and weekend work may be required as job duties demand.
Qualifications
Required:
• Bachelor's degree in Science or Engineering
• Minimum 2-4 years of quality engineering experience
• Experience supporting complex electro-mechanical, software-controlled systems for medical applications
• Experience with pFMEAs, Test Method Validations, Root Cause Analysis, CAPAs, Non-Conformance Management, and Process Validations
• Analytical and problem-solving skills
• Ability to work in a regulated environment in compliance with ISO 13485 and 21 CFR 820
• This position will be located in Santa Clara, CA site and may require up to 10% domestic or international travel
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsors
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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