Quality Engineer Associate I

Merz North America, Inc; Town of Caledonia (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vis

Paid Time Off

Paid Holidays

Job summary

Merz North America, Inc. seeks a QA/Regulatory professional to support nonconformance records, CAPA, change control, product surveillance, and risk management within the Quality System. You will partner with manufacturing and quality teams to drive compliance and continual improvement.

Responsibilities include investigating deviations, documenting root causes, reviewing procedures, and ensuring adherence to cGMP and FDA guidelines across projects and processes.

Qualifications

• Bachelor's degree or equivalent experience.
• BS/BA in Engineering or Physical Science preferred.
• GLP/GMP experience preferred.
• Medical Device experience preferred.

Responsibilities

• Execute NCR and CAPA investigations and root-cause analysis.
• Support Change Control processes and documentation updates.
• Support Product Surveillance and data/trend evaluations.
• Assist with risk management and annual product risk reviews.
• Ensure compliance with FDA, cGMP, and related guidelines.

Skills

GxP knowledge

cGMP familiarity

Quality systems experience

Data analysis

Documentation control

Education

Bachelor's degree or equivalent

BS/BA in Engineering or Physical Science

Tools

LIMS

Quality Management Software

Job description

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 regulations Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
• Other duties as assigned Provides support to Quality Management personnel and perform other duties as assigned.

Minimum Requirements

• Bachelor's Degree or equivalent experience

Preferred Qualifications

• Bachelor's Degree BS/BA in Engineering or Physical Science
• GLP/GMP experience
• Medical Device experience

Technical & Functional Skills

• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, and/or Validation.
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information.
• Management Systems (LIMS) and Quality Management software is highly preferred.
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
• Proficiency with all equipment in the lab, as well as equipment preventative maintenance and method/process troubleshooting.
• Familiarity with general laboratory and incoming supply inspection testing.
• Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis.
• Ability to prepare testing protocols and reports, operating documents and procedures.
• Ability to work with little or no supervision and make effective decisions.

Benefits

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.