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 Introduction. This position would include 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. 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
- 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.
- Change Control * 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.
- 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
- Support NCR and CAPA 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.
- Adherence to regulations Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) medical devices.
- Inspections * Support with federal, state, and local regulatory officials during regulatory inspections* Support in internal and vendor quality system audits as applicable
Minimum Requirements
- 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
Preferred Qualifications
- 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
- 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.
- 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!
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 DisabilitiesThis 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.
Top Skills
What We Do
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. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
