Quality Engineer Assoc I

Company: Jobleads
Location: Franksville
Posted on: May 3, 2021

Job Description:

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. 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 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 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 Professional 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. KNOWLEDGE or METHODS 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. PERSONAL SKILLS 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. Some clean room work may be required; no make-up or excessive amounts of jewelry allowed. Lifting of light to moderately heavy (less than 25 pounds) objects. Manual Dexterity. Qualifications Education Required Bachelors or better in Engineering or related field. 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)

Keywords: Jobleads, Kenosha , Quality Engineer Assoc I, Other , Franksville, Wisconsin