You will be responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. You will find areas of improvement and develop a solution. Additionally you will interact with customers and suppliers in support of engineering projects.

Responsibilities may include the following and other duties may be assigned:

Key areas of expertise are:

• • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Develop and maintain project Quality Plan for assigned projects.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material via NCR’s.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
    
    
    

Must Have:

• • Bachelor degree required, preferably in an engineering discipline.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
    
    
    

Good to have:

• • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Minimum experience in medical/manufacturing environment: 2-5 years
  • If you're the right person for this opportunity, you will have previous experience providing administrative support to a busy office and using Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.