Merz Aesthetics · 1 hour ago
Quality Engineer
Racine, WI
Full-time
Onsite
Entry, Mid Level
2+ years expMerz Aesthetics is a leading global aesthetics business that empowers healthcare professionals through its innovative products. The Quality Engineer position focuses on providing Quality Engineering and Technical Support for various departments, ensuring compliance with Quality Standards and Regulations while leading initiatives aimed at improving quality and operational efficiencies.
BiotechnologyHealth Care
No H1B
Responsibilities
Design Control Support operations, sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products
Risk Management Support Risk Management activities including review and coordination of quality activities related to risk
Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to operating 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
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
Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) medical devices
Support with federal, state, and local regulatory officials during regulatory inspections
Support in internal and vendor quality system audits as applicable
Qualification
Required
Bachelor of Science (B.S.) in Engineering or a related technical field (e.g., Biology, Chemistry)
2+ years in Medical Device or similar experience
2+ years in a quality role
2+ years working with electromechanical devices
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
Understanding of IEC 60601, 62304, RoHS, WEEE
Understanding of system software, firmware, and hardware integration
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
Preferred
ASQ Certification as a Quality Engineer or equivalent Upon Hire
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!
Company
Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Bob Rhatigan
CEO, Merz Aesthetics
Alana Sine
Chief Financial Officer
Recent News
2025-06-21
2023-05-26
Company data provided by crunchbase