Engineering Change Specialist I

Our Client is one of the world's largest Power generation industry is currently looking for Engineering Change Specialist I

LOCATION: La Prairie, Quebec 
CONTRACT: 8 months with a possibility of extension.
START DATE: ASAP (Urgent Need)
PAY TYPE: Hourly

Engineering Change Specialist I is responsible for development, implementation and maintenance of change control process to ensure the quality requirements in the manufacture and test of products devices. 

Key responsibilities:

  • Essential functions include Initial issuance of system documents to all locations and personnel referenced in the documents, for making approved revisions, distributing, and removal of obsolete documents 
  • Coordinate program milestone documentation releases 
  • Tracking and overseeing engineering change notices 
  • Facilitate change review board meetings 
  • Interface with the various teams who are responsible for creating, changing or releasing engineering tools Responsible for managing record retention. 
  • Responsible for developing and maintaining a control system for updating the computer database as required. 
  • Review and maintain accurate artwork files to support Manufacturing requirements. 
  • Adhere to current Good Manufacturing Practices, ISO, CE and internal procedures and policies. Comply with EHS regulations and policies 
  • Other tasks assigned by the manager 

Qualifications:

  • Bachelors Degree in Quality or Engineering or equivalent 
  • Minimum 2 years of experience working in a regulated environment 
  • Minimum 2 years of experience in QA Engineering disciplines 
  • Experience using word processing, spreadsheet, and presentation software 
  • Excellent oral and written communication skills. 
  • Analytical & problem-solving skills root-cause analysis. 
  • Strong organizational skills with high attention to detail. 
  • Demonstrated effective interpersonal and effective teamwork skills.

ewemi

Quality Assurance Specialist I

Our Client is one of the world's largest Power generation industry is currently looking for Quality Assurance Specialist I

LOCATION: La Prairie, Quebec 
CONTRACT: 8 months with a possibility of extension.
START DATE: ASAP (Urgent Need)
PAY TYPE: Hourly

The QA Specialist is responsible for leading the development and maintenance of Quality System metrics, reporting and operating mechanisms to help drive the site quality objectives. 

Key responsibilities include: 

Leading the development and maintenance of Quality System metrics, including but not limited to:

  • Complaint Metrics 
  • CAPA Metrics 
  • MDR C&R Metrics 
  • Audit Metrics 
  • Production and Process Control Metrics 
  • Training Metrics
  • Purchasing Metrics 
  • Design Control Metrics Supporting the preparation and execution of Quality Management Reviews at the site

Qualifications: 

  • B.S. Degree in business or technical field. 
  • 1 year experience in a medical device or pharmaceutical industry. 
  • 1 year experience with CA PA systems, including complaint handling. 
  • 1 year experience applying regulations (including FDA QSRs, ISO13485). 
  • Proficient with MS Office word processing, spreadsheet, presentation, and database applications. 
  • Ability to identify root cause of problem, and creatively problem solve to gain resolution. 
  • Ability to communicate effectively in English (both written and oral). 
  • Ability to work independently in fast-paced environment with little supervision. 
  • Ability to adapt to constant change and influence positive change effectively. 
  • Team-oriented and responsive to customer needs. 
  • Quality-Focused, Attentive to Detail and Results-Oriented.

ewemi