Quality Engineer - Medical Device Manufacturing

Company: Kelly Services
Location: Milpitas
Posted on: April 9, 2021

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Quality Engineer - Medical Device Manufacturing at a prestigious Fortune 500-- company working in Campbell, CA.-- This is a 6-month temporary position at 40 hours per week. Pay: $48.00/hr. +Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "submit now" button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position () however your resume must be received via the "submit now" button included within.JOB OVERVIEW: Position is responsible for direct interaction and support and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis: This position will report to the Director/Quality Assurance. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).ESSENTIAL FUNCTIONS:

• Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
• Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
• Develop and maintain the pFMEA process for manufacturing.
• Support/participate in regulatory agency and customer quality audits.
• Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
• Participate in initiating non-conformance report, Containment, root cause investigation, dispositions and implementation of CAPA.
• Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
• Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
• Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
• Provide quality engineering support to sending sites during project transfers.
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.QUALIFICATIONS:
  • BS/BA degree with a scientific/engineering emphasis required.
  • AQS Certified Quality Engineer or MS in Medical devices engineering, Engineering Management or Mechanical
  • Six Sigma Green/Black belt recommended
  • Minimum of 3 years' experience with MS in a related regulated medical device environment. Catheter/MI experiences an advantage.COMPENTENCIES:
    • Values: Integrity, Accountability, Teamwork, Innovation
    • Excellent verbal and written communication skills
    • Ability to work independently
    • Ability to manage tight timelines and changing priorities
    • Excellent problem-solving techniques
    • Proficient with Microsoft office applicationsPHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.PHYSICAL DEMANDS: --- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.--- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.--- Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.WORK ENVIRONMENT: --- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.TRAVEL: This position may require 20 % travel between sites and customer or supplier locations as required, dependent on the needs of the organizationWhy Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Milpitas , Quality Engineer - Medical Device Manufacturing, Other , Milpitas, California