Description
Role: Quality Assurance Engineer
Reports to Role: Quality Manager/ QA Director
PURPOSE -
Assists in assuring medical devices are designed and manufactured with high quality and reliability, within all domestic and international regulatory Quality Management System (QMS) requirements and meet or exceed customer expectations.
ACCOUNTABILITIES -
• Plans and conducts inspection of equipment validations.
• Responsible for the Environment Monitoring Program
• Responsible for monthly/quarterly/bi-annual/yearly product testing and analysis of data
• Collaborate with Post Market Surveillance – Investigations, track and trend of complaint data, PFA/HHE meetings
• Yearly Periodic Risk Assessment review
• Assist with external/internal audits
• Update create SOPs/ECOs and any related documents
• Interact with other departments to resolve development, manufacturing and/or customer issues.
• Leader model and coach other team members in EBS and QA
KNOWLEDGE, SKILLS & EXPERIENCE -
Critical Knowledge and Qualifications: what the role holder must know; including any required general or professional qualifications/ education)
• Bachelor's degree from a four-year College or University in an engineering discipline.
• Compliance certifications highly preferred.
• Must have knowledge of basic computer software applications such as Microsoft Word, Excel, PowerPoint, etc. or equivalent.
• Must be available to work in a flexible working environment
• Must have SAP knowledge
• Knowledge of ISO standards
• Internal/External audits
• Quality seminars, webinars and other quality events
Critical Skills/technical know-how: /what the role holder must be able to do.
• Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab
• Must have good project management, communication and collaborative skills working individually or with various functional teams
• Must be hands-on and able to multi-task to address existing and potential QA issues routinely.
Critical Experience:
• General FDA and international medical device regulations knowledge (i.e., 21 CFR Part 820, ISO 13485, MDD, JPAL and CMDR)
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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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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