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About this opportunity

The Global Quality System Engineer role forms part of the Global Quality Management Team, reporting directly to the Sr. Manager, Global QMS. This role is accountable for development & maintenance of the Global Quality System. Additionally, this role engages and supports Align Technology entities in harmonizing and aligning their processes to the Global QMS.

In this role, you will...

Establishment of Global Quality Management System:

• Facilitate baseline data gathering of multiple local / regional processes.
• Engage global process owners / representatives to communicate process development activities and to solicit input and support.
• Analyze processes against best in class compliant practices.
• Leverage a ‘SIPOC’ and ‘Lean’ approach to process development.
• Create visual process maps to define/capture procedural steps and integrate visual flowcharts into procedure development and/or eSystem design.
• Establish new procedures by managing the document approval process.

Maintain Compliance and Continually improve the Global Quality System:

• Execute Global Quality System processes in alignment with defined procedures.
• Administer Change Requests and Change Orders in alignment with Global QMS processes.
• Initiate, investigate, review and approve Quality Incidents relating to the Global QMS (inclusive Nonconformance, CAPAs, SCARs, and Field Corrective Actions.
• Identify process/system improvement opportunities.
• Present data to the Global Change Review Board (CRB) for process change consideration

Co-ordinate and Provide Global QS Training
• Establish and maintain Global QMS training curriculum and supporting training documents.
• Produce easy ‘on demand’ and/or ‘on the job’ training materials to ensure effective ‘just in time’ training.
• Manage all training materials under change and revision control.
• Provide and/or co-ordinate training activities in a timely manner.

Provide Data Gathering & Reporting Services
• Collate and report Global Quality Metrics, KPIs and/or Quality Scorecards.
• Produce data to support Global Quality Management Review in support of corporate governance.
• Ensure analytical data is provided from a verified or validated source.

Support Management with Audits and Inspections
• Provide timely support to local QMS teams during internal/external audits and inspections in respect to document/data requests.
• Support Global QMS during internal/external audits and inspections.
• Escalate Non-conformances and follow applicable procedures to manage issues to resolution.

In this role, you’ll need ...