Quality Engineer Associate I Temp Conversion Candidate Identified

About the Company:

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

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

Key Responsibilities: 

NCR and CAPA activities.
• Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Merz North America Quality System for NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformances, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Support Change Control activities.
• Originate, review, and approve internal operating procedures and specifications through the Document Change process.

Support Product Surveillance activities.
• Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analyzing the data for the reasons of Quality Improvement and reporting.

Support New Markets activities.
• Support New Markets activities including: management of new markets samples process; coordination between new markets group in Germany and WI Tech Ops to manufacture samples; filing of applicable new markets documentation in the Design History File (DHF).

Support Risk Management activities.
• Support Risk Management activities including: data preparation for annual product risk file review; review internal documents (IFU, CER, etc) for annual product risk file review; management and preparation of event-based reviews; review and coordination of quality activities related to pFMEA risk matrices.

Supports Internal and Vendor Audit Functions.
• Supports Internal and Vendor Audit Functions as needed.

R&D Support.
• Provide assistance, as needed, to the R&D department in the development and validation of new products.

Process improvement initiatives.
• Coordinates process improvement initiatives for the Quality Department.

Adherence to regulations.
• Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.

Other duties as assigned.
• Provides support to Quality Management personnel and perform other duties as assigned.

Education:
• Bachelor’s Degree or equivalent experience.

Required
• BS/BA in Engineering or Physical Science.

Preferred

Experience:
• GLP/GMP experience.

Preferred
• Medical Device experience.

Preferred

Knowledge Skills and Abilities:
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, and/or Validation.
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information.
• Management Systems (LIMS) and Quality Man...