Supplier Quality Engineer
|Job Title:||Supplier Quality Engineer|
|Contact Name:||Rachel Radford|
|Job Published:||March 15, 2017 14:51|
- Support and contribute to a Quality culture based upon risk management, process mastery, data-driven analytics and goal-oriented performance accountability.
- Quality representative for Supplier Quality activities, both troubleshooting/CAPA and continuous improvement initiatives.
- Determine strategies for continuous improvement in supplier quality metrics.
- Manage supplier corrective actions (investigation, documentation and implementation of corrective action and the verification of their effectiveness).
- Manage supplier-driven Change Requests.
- Review and approve changes to supplier related documents (procedures, drawing, etc.).
- Perform or review component qualifications, risk assessments, and first article inspections (as required) prior to the supplier implementing and/or performing the change.
- Participates in supplier's design review, product validation, design verification, Risk Management plans/reports (dFMEA, pFMEA).
- Performs risk analysis for existing and new raw materials / components.
- Develop and conduct statistically designed experiments to determine sources of material / component variability so that product quality is maintained or improved
- Monitor and assure the company's supply chain activity and procedure set is compliant with FDA quality system regulation and ISO 13485 standard.
- Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements e.g., EU IVDD, HPRA, FDA, Health Canada, etc.
- Understand new regulations and guidelines, as they apply to the company, and implement systems and procedures to incorporate these new regulations.
- Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs) for functional areas under responsibility.
- Maintain and execute a robust audit process of the Quality Management System.
- Maintain and execute a robust audit process of Supply Chain quality, working collaboratively with Operations Supply Chain management team.
- Technical knowledge of supplier processes and supplier products; critical-to-quality metrics; incoming quality control.
- Support product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, supplier audits.
- International travel (up to 20%) may be required.
- Minimum Education: Bachelor's degree in Engineering. Master's degree preferred.
- Six Sigma Black Belt Certified preferred.
- Experience of Statistical Process Control.
- Minimum Experience: 5 - 8 years of experience in Quality, Supplier Quality, Supply Chain or related process driven field in in vitro diagnostics or related industry
- Computer knowledge: MS Excel, MS Word, MS Power Point, MS Visio; statistical software packages such as Minitab, SAS JMP, etc.
- Quality System Audits knowledge (ISO 13485, ISO 9001), Lead Auditor Certification.
- Good manufacturing and documentation practices.
- Drawings and blueprints knowledge.
- Measurement and test equipment knowledge.
- Supply Chain quality assurance.
- Project management of change programs.
Please don't hesitate to apply if you feel this is a great fit for you!
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