Junior Medical Devices Quality Associate (2 Openings)(ONSITE)(No C2C/H1B)

Overview

On Site
Depends on Experience
Contract - W2
Contract - 18 Month(s)

Skills

Medical device experience
life science experience
ISO 13485
21 CFR Part 820
IVDR
SAP
product release
quality inspection
final kit-level inspection
document review
physical inspection
corrective actions
preventive actions
quality assurance
QAI training
compliance
manufacturing environment
analytical skills
detail-oriented
time management
multitasking
organization
fast-paced environment
inspection documentation.

Job Details

(No C2C/H1B)

Please note that this is a 6 to 18-month contract position.

Only local candidates need to apply.

Notes: needs to have medical device or life science experience. Also should understand these compliance terms: Ensures compliance with relevant regulations and guidelines, ISO 13485, 21 CFR Paart 820, and IVDR.


Qualifications

  • Bachelor s degree required.
  • 1-2 years relevant quality experience in a manufacturing environment.
  • 1+ years of SAP experience.
  • Focused on product release processes, ensuring accuracy and timeliness.
  • Must be analytical, detail-oriented, and possess strong time management skills.
  • Ability to multitask, stay organized, and prioritize effectively in a fast-paced environment.

Primary Responsibilities:

  • Support intermediate and final kit level inspection and final product release for high-profile product lines.
  • Identifies opportunities for improvement in Quality processes for Cedar Creek reagent products and consumables and implements corrective and preventive actions accordingly
  • Performs final physical inspections of the product.
  • Completes documentation for all inspections.
  • Uses SAP to perform all computer-related tasks.
  • Supports final product release of Cedar Creek products via physical inspection and document review.
  • Ensures compliance with relevant regulations and guidelines, ISO 13485, 21 CFR Paart 820, and IVDR.
  • Assists with training related to Quality Assurance Inspection - QAI.

Applicants must provide their phone number. Reference job number is A4878

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