Quality Control Lead

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.

Schedule 3:30 - 12:00 PM

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