Quality Engineer INT in Sturtevant, WI at Volt

Date Posted: 9/26/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Duration:
    48 weeks
  • Date Posted:
    9/26/2018
  • Job ID:
    139962
  • Pay Rate
    $0.0 - $35.0/Hour
  • Contact Name
    Volt Branch

Job Description

Position: Quality Engineer INT

Location: Sturtevant, WI

Status: 12-month contract

Volt Workforce Solutions has an immediate opening for a Quality Engineer INT with our client in Sturtevant, WI. This is a 12 month contract position.  

This position is responsible for providing engineering and technical support to the Quality Department.  This position would support a wide array of activities related to Change Control, NCR/CAPA, Product Surveillance, New Markets and Risk Management.  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 indicated.  Provide direct support to Quality personnel regarding operation of the department and Quality System.  Provide support to other departmental activities as directed.

Essential duties and responsibilities

  • Change Control activities = Originate, review, and approve internal operating procedures and specifications through the Document Change process
  • Support NCR and CAPA activities = Corrective/Preventive actions and product non-conformance control 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.
  • 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

Requirements:

  • BS in a Physical Science or Engineering plus 3 years of experience in medical device or pharmaceutical and/or equivalent regulated industry
  • Knowledge of regulatory requirements for medical device / pharmaceutical organization
  • Strong technical and general problem-solving skills required; experience with NCR/CAPA processes
  • Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software
  • Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
  • Medical Device Risk Management regulation ISO 14971, preferred
  • Experience in performing internal and/or supplier audits, preferred
  • experience with the sterilization of medical devices
  • Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization
  • Manage multiple priorities and work with interruptions.  
  • Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

Please apply to position or contact Debbie Linville at 317-599-4893 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer