Quality Engineer Associate I

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history.

As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine.

Our purpose is to fuel confidence by helping people look better, feel better, and live better.

We believe you do not have to choose between living life and making a living.

Live your best life with Merz Aesthetics.

A Brief Overview

This position supports a wide array of activities related to: Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Change Control, Product Surveillance, Design Control, New Markets and Risk Management.

Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.

Provide direct support to Quality personnel regarding operation of the department and Quality System.

Provide support to other departmental activities as directed.

What You Will Do


* NCR and CAPA activities Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Merz North America Quality System for NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformances, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.


* Support Change Control activities Originate, review, and approve internal operating procedures and specifications through the Document Change process.


* Support Product Surveillance activities Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analyzing the data for the reasons of Quality Improvement and reporting.


* Support New Markets activities Support New Markets activities including: management of new markets samples process; coordination between new markets group in Germany and WI Tech Ops to manufacture samples; filing of applicable new markets documentation in the Design History File (DHF).


* Support Risk Management activities Support Risk Management activities including: data preparation for annual product risk file review; review internal documents (IFU, CER, etc) for annual product risk file review; management and preparation of event-based reviews; review and coordination of quality activities related to pFMEA risk matrices.


* Supports Internal and Vendor Audit Functions Supports Internal and Vendor Audit Functions as needed.


* R&D Support Provide assistance, as needed, to the R&D department in the development and validation of new products.


* Process improvement initiatives Coordinates process improvement initiatives for the Quality Department.


* Adherence to regulatio...