Date Posted: September 08, 2017
Employment Type: Contract To Hire
Job Id: 7877
- Monitoring and improvement of product quality.
- Defect, scrap and rework prevention.
- Continuous improvement of and adherence to Quality Management System.
- Control, document, evaluate and disposition nonconforming materials.
- Coordinate and monitor inspection activities.
- Investigate, document and communicate customer complaints. Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements
- Coordinate and perform Corrective Action and Preventive Action activities as required.
- Internal auditing as required.
- Provide guidance on regulatory requirements.
- Perform and/or prepare installation, operational, and performance qualification of equipment as needed.
- Provide product specifications and task specific instructions for use by Assembly and Quality,
- personnel and when required specifying the type of inspection or measuring equipment to be utilized.
Required Skills, Knowledge and Expertise'
- Sr QE expected to be skilled in/very knowledgeable of below
- QE 2 expected to have basic understanding of I able to practice below
- QE 1 expected to be familiar with and learning below
- ISO 9001 and 13485
- Medical Device Directives and product – specific applicable standards
- FDA Quality System Regulations
- Canadian Medical Device Regulations
- EtO sterilization
- Gamma Sterilization
Education, Certification and Experience
- BS in Engineering, Biology or related science preferred
- Quality and/or Regulatory experience in Medical Device manufacturing preferred,
- ASQ CQE certification preferred