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Quality Control Lead

Inari Medical
Irvine, CA Full Time
POSTED ON 8/24/2024 CLOSED ON 9/22/2024

What are the responsibilities and job description for the Quality Control Lead position at Inari Medical?

Description

The Quality Control (QC) Lead is a highly skilled individual that contributes to the development of concepts and techniques. Completes complex tasks in creative and effective ways. Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.

QC Lead helps assign QC tasks among incoming, in-process, and finished product inspection; product validation testing and Administrative Return Merchandise Authorization (RMA-A) to ensure all business needs and department goals are fulfilled. The lead has an active role in training and developing QC personnel.

Responsibilities

  • Coordinate with local leadership as well as leadership of Production, Warehouse, and
  • Engineering to perform raw material, in-process, and finished products, returned products, and other quality related inspections.
  • Review receiving inspection records, develop and support procedures via support redline initiation.
  • Utilize Visual Inspection Systems and other inspection tools (tensile strength machines/calipers/pin gauges/etc.) per inspection requirements.
  • Coordinate and delegate daily priorities to ensure accurate and timely completion.
  • Maintain accurate records for compliance with regulations.
  • Review documentation for accuracy, completion, legibility in alignment with Good Documentation Practices (GDP).
  • Ensure adherence to regulations and internal quality procedures.
  • Assist in department inventory control activities and organizational initiatives.
  • Assist in the evaluation and setting up of new inspection equipment.
  • Train new employees in inspections and procedures.
  • Provide guidance and continuous support to QC Inspectors.
  • Review out-of-specification results with engineering and initiates NCRs as required.
  • Review Lot specifications for QC Digital Data Sheets.
  • Assist with Receiving Inspection Records per Management direction.
  • Process non-conforming materials/products according to NCR disposition.
  • Provide cross-functional support to peripheral projects and assignments as needed.
  • Ensure necessary supplies, instruments, and equipment are available.
  • Perform other activities as required.

Qualifications

  • High school diploma or equivalent preferred.
  • Minimum 5 years of QA/QC experience with medical device manufacturer.
  • Prior experience in regulated environment (e.g. FDA QSR, ISO 13485, etc.)
  • Good attention to detail.
  • Able to work independently with minimal supervision.
  • Able to prioritize and efficiently complete tasks with consistency and accuracy.
  • Able to lead, provide clear direction, delegate tasks, and train team members.
  • Able to interpret blueprints.
  • Computer skills including Word, Excel, and Internet experience.

Preferred

  • Cleanroom experience preferred.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $29.00- $36.00. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.

Salary : $29 - $36

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