Quality Engineer Associate I

Merz North America•Franksville, WI

11d

About The Position

This position supports a wide array of activities related to: Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Change Control, Product Surveillance, Design Control, New Markets and Risk Management. Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

Requirements

Bachelor's Degree or equivalent experience
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.
Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
Proficiency with all equipment in the lab, as well as equipment preventative maintenance and method/process troubleshooting.
Familiarity with general laboratory and incoming supply inspection testing.
Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis.
Ability to prepare testing protocols and reports, operating documents and procedures.
Ability to work with little or no supervision and make effective decisions.
Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Nice To Haves

BS/BA in Engineering or Physical Science
GLP/GMP experience
Medical Device experience
Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information. Management Systems (LIMS) and Quality Management software is highly preferred.

Responsibilities

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.
Originate, review, and approve internal operating procedures and specifications through the Document Change process.
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 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 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 as needed.
Provide assistance, as needed, to the R&D department in the development and validation of new products.
Coordinates process improvement initiatives for the Quality Department.
Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
Provides support to Quality Management personnel and perform other duties as assigned.