Description
Requirements – Quality Engineer
• Must have prior experience with ISO cleanrooms
• BS in Chemical, Biomedical, Mechanical, or Industrial Engineering
• 5 to 7 years minimum experience in an FDA regulated environment.
• ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.
• Experience with Quality System Regulation (QSR), ISO, Design Control and Process
Validation guidelines.
• Lyophilization preferred
• Knowledge of qualifying new facility additions - HVAC, water filter systems
• med device experience preferred not required
• Able to develop technical documentation such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others.
• Will have a fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements.
• Will have a basic understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
• Will be able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
• Will be able to plan, control and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling and measurement systems.
• Will have basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, assessment tools and reporting.
• Will have a thorough understanding of problem-solving and quality improvement tools and techniques.
• Will be able to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
• Problem solving and analytical thinking skills
• Strong Project Management skills
• Strong skills in technical writing
• Knowledge in Lean and Six Sigma concepts
• Knowledge of statistical techniques: SPC, DOE, Process Capability and Gage R & R, etc.
• Use of statistical process Minitab tools is preferred.
• Working knowledge of computers and business software (MS Office, MS Project, VISIO) required.
• Experience in biomaterials preferred.
• Experience in cGMP, cleaning methods and validations preferred.
• Ability to interact cross-functionally required.
• Strong interpersonal skills
• Teamwork oriented and self-starter
• Fully bilingual (English/Spanish)
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?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.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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