Senior Quality Engineer-EBD

Merz Aesthetics; Racine (WI); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vision plans

20 days of Paid Time Off

15 paid holidays

Paid Parental Leave

401(k)

Employee bonuses

Job summary

A global aesthetics company in Racine, Wisconsin, is looking for a Quality Engineer to provide technical support for operational processes and ensure compliance with regulatory standards. You'll be responsible for managing quality initiatives, supporting CAPA, and contributing to product development and changes. Ideal candidates will have a Bachelor's degree in Physical Science or Engineering and over 6 years of experience in a regulated industry. Strong problem-solving and writing skills are essential, and comprehensive benefits are provided.

Qualifications

• 6+ years of experience in a regulated industry, with 3+ years in a Quality Engineering role.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and Risk Management.
• Experience with CAPA, NCRs, and Change Control.

Responsibilities

• Provide quality engineering support for supplier changes and quality improvement initiatives.
• Review change requests and assess impacts on product design.
• Support internal and external quality audits and regulatory inspections.

Skills

Knowledge of quality requirements for medical devices

Strong technical writing skills

Ability to analyze product changes

Strong problem-solving skills

Computer skills in MS Office and Quality Software

Effective communication skills

Education

Bachelor of Science (B.S.) in Physical Science or Engineering

Tools

Quality System Management Software

Microsoft Word

Microsoft Excel

Visio

Adobe

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 is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position includes supporting a wide array of activities related to Change Control, NCR/CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. 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

• Change Control: Review change requests and identify impact on product design and documentation. Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as review 3rd party design control activities.
• Design Control: Documentation review for technical accuracy and compliance to procedures. Review Technical Writing and Documentation. Support operations, sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
• Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Work with manufacturing and other functional groups on manufacturing regulatory compliance issues. Support training programs by delivering assigned tasks.
• Support NCR and CAPA: Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for reasons of Quality Improvement and reporting.
• Risk Management: Support Risk Management activities including review and coordination of quality activities related to risk.
• Inspections: Support with federal, state, and local regulatory officials during regulatory inspections. Support internal and vendor quality system audits as applicable.
• Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
• Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.

Minimum Requirements

• Bachelor of Science (B.S.) in Physical Science or Engineering, or equivalent experience.
• 6+ years experience in a regulated industry (medical device, pharma, biotech, or similar), including 3+ years in a Quality Engineering or Quality-focused role.
• Working knowledge of:
  • ISO 13485
  • FDA 21 CFR 820
  • Risk Management (ISO 14971)
  • CAPA, NCRs, Deviations
  • Change Control / Change Management

Preferred Qualifications

• Quality Role.
• Experience with electromechanical or software-enabled medical devices strongly preferred.
• ASQ Certification as a Quality Engineer or equivalent.

Technical & Functional Skills

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Strong technical writing skills.
• Ability to analyze product changes and identify their impact.
• Strong technical and general problem-solving skills; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Understanding of system software, firmware, and hardware integration.
• Familiarity with statistical sampling requirements for Design Verification and Process Validation.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Ability to manage multiple priorities and work with interruptions.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

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.