Quality Investigations Engineer

Merz Aesthetics; Franksville (WI); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vis

20 days PTO

401(k) with employer match

Job summary

Merz Aesthetics is seeking a Quality Engineer to support operations, sustaining engineering, R&D, and new product introductions. You will work on NCR/CAPA processes, CAPA reviews, and regulatory compliance activities to ensure manufacturing quality and product integrity.

The ideal candidate has a BS in Engineering, 2+ years in medical devices, and ASQ certification is a plus. The role emphasizes cross-functional collaboration, audits, and continuous improvement in a fast-paced environment.

Qualifications

• BS in Engineering or equivalent experience.
• 2+ years in Medical Device or similar industry.
• ASQ Certification as Quality Engineer preferred.

Responsibilities

• Identify and drive quality improvement initiatives compliant with cGMP.
• Support NCR/CAPA processes including investigations and data capture.
• Assist with regulatory inspections and quality system activities.

Skills

Quality engineering

Regulatory compliance

Problem solving

Communication

Decision making

Education

BS in Engineering

ASQ Certification as Quality Engineer (preferred)

Tools

Microsoft Word

Excel

PowerPoint

Visio

Access

Quality System Software

Adobe

Job description

About UsFounded 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.

About UsFounded 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 Introduction. This position would include supporting NCR and CAPA activities. This position would 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

• Quality Initiatives: Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Works with manufacturing and other functional groups on manufacturing regulatory compliance issue. Support training program by delivering assigned training tasks
• NCR and CAPA: Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances (NCR), CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. Conduct CAPA and NCR review and approvals. Run the Material Review Board (MRB)
• Adherence to Regulations Assist with adherence to all Federal, State and Local Regulations controlling the manufacture medical devices, cosmetics, and pharmaceuticals.
• Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Other duties as assigned. Provides support to Quality Management personnel and perform other duties as assigned Remote Work Eligibility. Allowed up to 2 days per week in accordance with policy
• Management: For those who manage or supervise staff: Manage staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Minimum Requirements

• Bachelor of Science (B.S.) in Engineering or equivalent experience
• 2+ years in Medical Device or similar experience

Preferred Qualifications

• 2 years in a quality role
• ASQ Certification as a Quality Engineer or equivalent Upon Hire

Technical & Functional Skills

• Knowledge of regulatory requirements for medical device / pharmaceutical organization
• Strong technical and general problem-solving skills required; experience with NCR/CAPA processes
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software
• Familiar with ISO 13485 Quality System Standards, ISO 14971, 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.
• 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.