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Quality Assurance Specialist I - North Chicago, United States - US Tech Solutions, Inc.
Description
Job Title: Quality Assurance Specialist I (Med Device Complaints)
Location: North Chicago, IL Onsite)
Duration: 6 months contract
Work Schedule:
• First shift, Overtime is offered.
• Some aspects that can be done from home.
Job Description:
Individual will work in Post Market QA organization investigating return samples for medical device and combination product complaints and inquiries . Responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system . Interface with internal customers regarding product complaints. Responsibilities may include interaction with various third parties.
Responsibilities:
• Work in a laboratory setting wearing Personal Protective Equipment (e.g., gloves, lab coat, safety glasses).
• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing complaints that involve a non-medical quality related problem.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. Responsible that complaint data meets all regulatory requirements.
• Identification of potential reportable events and notification to appropriate functional groups and management.
• Reviews documents and recommends changes to help ensure team objectives are met.
• Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes. Takes initiative to be a key player in team activities.
• Completes special projects in resourceful and effective ways to support overall group needs and requirements.
Skills:
• Able to use time efficiently and effectively to complete workload.
• Good organizational skills.
• Knowledge and application of computer systems for word processing.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Preferred (but not required) skills:
• Lab experience, bio-hazardous lab.
• Experience with pharmaceutical or medical devices.
• Pharmaceutical experience.
• Complaint investigation experience .
Education:
• A Bachelor's Degree in technology or scientific background preferred or 1-2 years of relevant work experience.
Work environment:
• Biohazard lab.
• PPE (Safety glasses, Labcoat, gloves) required.
• Comfortable working with Sharps (needles) may contain biohazard material.
