Company Description

Sklar Instruments is a global provider of quality medical devices and supply chain solutions for the operating room. With a portfolio of over 20,000 products, Sklar offers surgical instruments, custom sterile procedure trays, instrument sets, patient safety, cleaning, and disinfectant products.

OVERVIEW

The Quality Assurance Lead is a well-seasoned individual with product and process knowledge having the background and ability to analyze, evaluate, and report compliance and noncompliance issues relative to documented procedures, work instructions, and records. This individual will participate in the reporting and resolution of internal and external quality issues in accordance with documented procedures. Must be detail-oriented and well organized.

RESPONSIBILITIES

Quality Related

· Ensure compliance with quality assurance/quality control procedures and work instructions that impact the finished product

· Liaison with the sales, purchasing and quality control teams on an ongoing basis to ensure appropriate processes are in place so that customer satisfaction levels are achieved

· Maintain supplier communication regarding nonconformances

· Understand the organization’s Quality Policy and help the organization to meet its Quality Objectives

TASKS

General

· Develop and maintain proficiency in all required computer programs required for this position

Quality Related

· Investigate customer complaints to determine root cause and any necessary corrective actions. Evaluate the retuned products to validate the reported issue. Arrange to have the products sent to the repair facility for rework if applicable, or back to the OEM supplier for further investigation if necessary.

· Maintain calibration of all measuring equipment

· Maintain regular communication with the Quality Control Lead

· Train new quality team members on relevant procedures and/or work instructions and answer questions or concerns as they arise

· Review nonconformances with QC reps to determine disposition and notify suppliers of any issues

· For repairs, supply estimates as requested, enter the orders and inspect the products when returned from the repair facility to confirm the work stated to have been done was and that the instruments function properly. Arrange to have the products shipped back to the customer.

EXPERIENCE

· Proficiency in Microsoft Office programs

· Knowledge of and experience adhering to ISO standards

· Demonstrated leadership, communication, presentation, training, team facilitation skills and the ability to work cross-functionally

· Ability to work effectively with minimal supervision

· Ability to communicate effectively, both orally and in writing

Sklar Instruments

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Quality Assurance Lead