Quality Investigations Engineer

Career Opportunities at Merz; Franksville (WI); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO 20 days

Holidays 15

401(k)

Job summary

Merz Aesthetics in Wisconsin seeks a Quality Engineer to provide Quality Engineering and technical support for operations, sustaining engineering, R&D, and New Product Introduction, including NCR and CAPA activities to ensure compliance with quality standards and regulations.

You will lead quality initiatives, support regulatory inspections, manage NCR/CAPA workflows, and collaborate with manufacturing and other teams.

Qualifications

• BS in Engineering or equivalent.
• 2+ years in Medical Device or similar experience.
• ASQ Certification as a Quality Engineer or equivalent would be a plus.

Responsibilities

• Lead quality initiatives to improve compliance and efficiency.
• Support NCR/CAPA investigations and MRB processes.
• Assist with federal, state, and local regulatory inspections.
• Provide training and guidance for quality systems and document control.
• Collaborate with manufacturing and R&D to drive Quality improvements.

Skills

Quality engineering

Regulatory knowledge

NCR/CAPA processes

Problem solving

Education

Bachelor of Science in Engineering

Tools

MS Office

Quality System Software

Job description

Job Category: Quality Systems/Customer Satisfaction

• Full-Time
• Hybrid

Locations

Showing 1 location

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 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
• 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.
• 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!

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.