Senior Quality Engineer

Senior Quality Engineer – Merz Aesthetics

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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.

This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. It includes 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. The role evaluates the operation of Manufacturing and Quality activities in relation to compliance with Quality Standards and Regulations and recommends where corrections or improvements are needed.

It provides direct support to Quality personnel regarding operation of the department and Quality System and supports other departmental activities as directed.

• Change Control:
  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.
• Design Control/Documentation:
  Review documentation for technical accuracy and compliance with procedures. Review Technical Writing and Documentation. Support operations, sustaining engineers, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
• Quality Initiatives:
  Provide quality engineering support for supplier changes and resolution of issues ntify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Work with manufacturing and other functional groups on manufacturing regulatory compliance issues. Support the training program by delivering assigned training tasks.
• Support NCR and CAPA:
  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 reasons of Quality Improvement and reporting.
• Risk Management:
  
  Support Risk Management activities including review and coordination of quality activities related to risk.
• Inspections:
  Support with federal, state, and local regulatory officials during regulatory inspections. Support in internal and vendor quality system audits as applicable.
• Adherence to Regulations:
  Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non‑EMD medical devices.
• Other duties as assigned:
  Provides support to Quality Management personnel and perform other duties as assigned.

• Bachelor of Science (B.S.) in Physical Science or Engineering, or equivalent experience.
• 3‑5 years in Quality Engineering roles.
• 6‑7 years in Medical Device or Pharmaceutical Industry or similar experience.

• Experience working with electromechanical devices.
• ASQ Certification as a Quality Engineer or equivalent.

• 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,…