Merz Aesthetics ยท 3 hours ago
Senior Quality Engineer
Racine, WI
Full-time
Onsite
Senior Level
6+ years expMerz Aesthetics is a leading global aesthetics business with a rich history, empowering healthcare professionals through aesthetic medicine. The Senior Quality Engineer will provide Quality Engineering and Technical Support for various departments, ensuring compliance with quality standards and regulations while supporting product development and manufacturing processes.
BiotechnologyHealth Care
No H1B
Responsibilities
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
Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products
Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies 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-conformances 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
Support Risk Management activities including review and coordination of quality activities related to risk
Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices
Provides support to Quality Management personnel and perform other duties as assigned
Qualification
Required
Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience
3-5 years Quality Engineering Role
6-7 years Medical Device or Pharmaceutical Industry or similar experience
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 required; 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
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
Working with electromechanical devices
ASQ Certification as a Quality Engineer or equivalent
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