Quality Assurance Associate - Irvine, United States - Inari Medical

Inari Medical
Inari Medical
Verified Company
Irvine, United States

1 month ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Description:

The Quality Assurance Associate, under direct supervision, supports efficient operation of the Quality Assurance department and compliance to FDA GMP, ISO 13485, MDSAP and other applicable regulatory requirements.


Responsibilities

  • Organize and digitize Quality files.
  • Review training records for manufacturing personnel.
  • Compile device history records and release lots into inventory.
  • Submit samples for pyrogen and bioburden testing to test labs.
  • Audit activities include supporting external audits and addressing audit findings.
  • Work with other members of the QA team to achieve departmental/company goals.
  • Review inprocess subassembly and finished product manufacturing routers (including engineering/R&D builds) for accuracy and completeness.
  • Identify and implement any changes necessary to the quality systems and compliance procedures to ensure and maintain the continued suitability and effectiveness of the quality management system.
  • Review documentation for International Shipments.
  • Other duties as assigned.

Qualifications

  • High school diploma or equivalent.
  • Minimum 3 years QA/QC experience.
  • Detail oriented and organized.
  • Good interpersonal, verbal, and written communication skills.
  • Prioritize and efficiently complete tasks with consistency and accuracy.
  • Proven proficiency using Microsoft Office and the Internet.
  • Knowledge of 21 CFR 820, ISO 13485 and other applicable regulatory standards.

Preferred

  • Bachelor's degree in Engineering or related technical field preferred.
  • Experience with medical device manufacturer preferred.
Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $24.00-$29.00. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.
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