Quality Engineer/ Sr. Quality Engineer

About the Company:

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany.

Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

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.

Key Responsibilities: 

Change Control:


* Support/Lead 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/Lead 3rd party supplier management activities such as review 3rd party design control activities. 

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. 

Design Control:


* Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new.

products.  

Risk Management:


* Support / Lead Risk Management activities including review and coordination of quality activities related to risk. 

Inspections:


* Support/Lead with federal, state, and local regulatory officials during regulatory inspections.


* Support/Lead in internal and vendor quality system audits as applicable.

Quality Initiatives:


* Identifies and implements 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/Lead training program by developing, coordinating, and delivering assigned training tasks. 

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. 

Management:


* For those who manage or supervise staff: Manage staff ...