Manufacturing Quality Engineer

Merz North America, Inc.; Franksville (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare company in Franksville is seeking a Quality Engineer to ensure the quality of manufacturing processes for electromechanical devices. The role involves coordinating teams to address quality issues, supporting compliance with regulations, and engaging in audits. Candidates should have a Bachelor's Degree in Physical Science or Engineering and at least 2 years of quality experience in the medical device or pharmaceutical industries.

Benefits

Comprehensive Medical, Dental, and Vision plans

20 days of Paid Time Off

15 paid holidays

401(k)

Qualifications

• 2+ years in Medical Device or Pharmaceutical Industry experience.
• 2+ years in a Quality Role.
• 2+ years working with electromechanical device manufacturing.

Responsibilities

• Coordinate teams to solve manufacturing quality problems.
• Support manufacturing investigations and implement corrective actions.
• Participate in regulatory inspections and audits.

Skills

Quality testing (electrical systems)

Statistical Analysis of Data

Technical writing skills

Communication skills

Teamwork

Education

Bachelor's Degree in Physical Science or Engineering

Tools

Power BI

Microsoft Excel

Quality System Management Software

Job description

Overview

Job Category: Quality Systems/Customer Satisfaction

Requisition Number: MANUF004329

Locations: Showing 1 location

About Us: 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. Live your best life with Merz Aesthetics.

A Brief Overview: The Contract Manufacturing Organization (CMO) Quality Engineer position will ensure quality in the day to day activities of the manufacturing organizations of our electro mechanical devices. It will ensure products meet established quality standards throughout the manufacturing process. The position will also provide direct support to Quality Management/Quality Engineering personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed. This position performs a wide array of activities related to: Manufacturing Support, Change Control, Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Product Surveillance, New Markets and Risk Management. Manufacturing Support will include but not limited to: monitoring and improving first pass yield, analyzing sources of and reducing scrap, analyzing sources of quality issues and prompt resolution. It will also ensure the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.

What You Will Do

• Quality and Manufacturing Operations: Coordinate teams to solve manufacturing quality problems in a timely fashion. Example tasks include analyzing scrap data and identifying methods of reduction; reviewing yield data and recommending process improvements to increase yield; reviewing process flow to identify inefficiencies and methods to improve throughput; acting as a liaison between quality and contract manufacturing departments; initiating and/or supporting the development of protocols and final reports for manufacturing or other quality control projects; supporting manufacturing needs by ensuring proper testing is in place for raw materials, finished goods, validation, in-process material and final products, completed accurately, timely and documented correctly.
• Quality Test Data-Metrics: Support manufacturing investigations and implement corrective and preventive actions to improve product quality. Analyze quality data and identify areas for improvement.
• Quality System Support: Support other Quality System functions as assigned by Quality Management related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventive Actions, product complaint investigations (if applicable), audits, and other tasks as directed.
• Audit Support: Participate with federal, state, and local regulatory officials during regulatory inspections. Support internal and vendor quality system audits.
• Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
• Other duties: Provides support to Quality Management and Engineering personnel and perform other duties as assigned.
• Qualifications: Bachelor\'s Degree in Physical Science or Engineering or equivalent experience. 2+ years Medical Device or Pharmaceutical Industry or similar experience. 2+ years in a Quality Role. 2+ years working with electromechanical device manufacturing or contract manufacturing. 2+ years in Manufacturing Quality or Operations Role.

Preferred Qualifications

• Experience with Power BI or equivalent tool.
• ASQ Certification as a Quality Engineer or equivalent.

Technical & Functional Skills

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Quality experience should include quality testing (electrical systems), QA/Regulatory, and/or Validation.
• Experience with Statistical Analysis of Data.
• Experience with Statistical Sampling requirements for Process Validation.
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
• Ability to prepare testing protocols and reports, operating documents and procedures.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Significant experience in root cause analysis tools, CAPA, NCR, SCAR investigations.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Experience with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Strong technical writing skills.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Demonstrated history of teamwork and cross functional collaboration.

Benefits

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

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

Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.