Randstad USA
JOB DETAILS
LOCATION
Chicago, IL
POSTED
6 days ago

Description

job summary:

Our Chicago-based enterprise financial services client is seeking an Associate-level Quality Design / Assurance Engineer to join their growing Life Sciences practice to support new demand across Medical Device client base.

Top 5 Skillsets Required

  • Bachelor's Degree in Life Sciences, Engineering, Biomedical or related field required
  • 3 years of Quality Design & Assurance Engineering experience required
  • 2 years of experience designing History Files, conducting Gap Analyses, and Quality Remediation work
  • 3 years of professional work experience within the Medical Device industry
  • EMDR (Electronic Medical Device Reporting) Regulation experience is a big plus

Key Responsibilities

  • Design and validate test methods for evaluating product reliability.
  • Develop procedures for inspecting and testing of finished products.
  • Responsible for performing analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
  • Manage complaint system, tracking timely investigation and closure of complaints. Work cross functionally to help identify root cause and any necessary corrective actions.
  • Responsible for initiating corrective actions and driving root cause analysis and resolution of issues through team members as necessary.
  • Design Control & Product Development
  • Represent Quality in Risk Management (Risk Management Plans, FMEAs, Hazards Analysis)
  • Initiate product Quality Plans
  • Represent QA in new product development projects and design changes to existing products
  • Provide input into component and process quality requirements
  • Write/review and approve test protocols and reports, establish sampling plans
  • Provide input on design-for-quality matters
  • Provide leadership for sterilization validation and biocompatibility testing
  • Support transit validations and product shelf life testing activities
  • Tooling and Calibration
  • Implement in-process and final inspection tooling and fixturing
  • Review tooling requirements and perform IQ/OQ/PQ as necessary
  • Oversee Preventive Maintenance and Calibration activities

Qualifications

  • Bachelor's degree in Electrical Engineering or equivalent, preferably in life sciences, biomedical
  • Must have minimum 3 years of experience in a medical device company
  • Working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 60601-01
  • Working knowledge of product reliability testing, electrical trouble shooting skills, PCBA, Device functional test development
  • Have working knowledge of sterilization, biocompatibility, and transit/shelf life standards
  • Have mechanical skills and have the ability to solve problems effectively
  • Must be detail oriented, well organized and have excellent communication skills. Must work well with team.
  • Must be able to accomplish objectives with minimal supervision.
 
location: CHICAGO, Illinois
job type: Contract
salary: $40 - 50 per hour
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:

listed above

 
qualifications:
  • Experience level: Entry Level
  • Minimum 3 years of experience
  • Education: Bachelors (required)
 
skills:
  • Quality (3 years of experience is required)
  • Quality (3 years of experience is required)
  • Medical Device (3 years of experience is required)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

About the Company

Randstad USA logo

Randstad USA

Randstad was founded in 1960 by Frits Goldschmeding. We've never let go of his passion or the values that he established. By staying true to those fundamentals, we've expanded to represent more than 90 percent of the HR services market.

We provide outsourcing, staffing, consulting and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing. We can’t wait to tell you all about it.

Our mission is to be a world leader in matching demand for, and supply of, labor and HR services. We believe in the value of work as a unifying force that shapes society for the better. We live by the core values established early in our company's history: to know, serve and trust, striving for perfection and simultaneous promotion of all interests.

COMPANY DETAILS
COMPANY SIZE
10,000 employees or more
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1960
WEBSITE
https://www.randstadusa.com/