Quality Assurance Associate - Irvine, United States - Inari Medical
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.
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