Quality Engineer Associate I Temp Conversion Candidate Identified - Merz North America, Inc

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 Management software is highly. Preferred
• 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.

Benefits:

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Quality