Senior Quality Engineer

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

The Senior Quality Engineer is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities.

Additionally, this position will operate as a liaison among the various R&D functions and the Quality Operations departments.

What you will do



* R&D Project Teams:
+ Responsible for supporting Medical Devices Project Teams and attending meeting in a Quality consultancy capacity
+ Support document reviews and regulatory submissions
+ Effectively manage project timelines as defined by department, project team, and corporate objectives


* Risk Management:
+ Facilitate and provide input to risk management activities throughout all stages of the device development process
+ Manage the risk management plan, risk file and risk report for assigned projects


* Human Factors Engineering:
+ Facilitate and provide input to human factors/usability activities throughout all stages of the device development process
+ Manage the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report


* Design & Development:
+ Facilitate and provide input to Medical Device manufacturing and Design & Development activities throughout all stages of the device development process (i.e.

general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
+ Provide input and review Design & Development documentation for assigned projects


* Audits/Inspections:
+ Support R&D related audits, both internal and external
+ Support R&D vendors/suppliers qualifications
+ Support all Merz regulatory authority inspections and certification body audits, as applicable


* General R&D Support:
+ Lead NCR efforts for the R&D area
+ Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives


* R&D Quality Improvements:
+ Facilitate and support harmonization initiatives within the R&D group
+ Facilitate and support projects to i...