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
Minimum 6 years Quality System Engineering Experience within a Medical Device Company aligned to ISO13485 & 21CFR820.
Minimum 6 years’ experience Medical Device experience and regulatory understanding.
Internal and external regulatory audit / inspection support.
Experienced in working as part of a multi-national Quality Management System team.
Experienced in coordinating the compliant use of electronic quality system applications.
Experience working across cross-functional global teams.
Lean / Value stream - Process Mapping
SOP / WI development and implementation.
Strong IT skills and demonstrated understanding of hardware and software platforms.
Ability to interpret FDA and other regulatory agency regulations and guidelines.
Receptive to working in a dynamic, fast-paced, constantly changing work environment.
Can work collaboratively with others and be aware of cultural differences at the global level.
Ability to role model compliance behavior’s in all situations.
Carry out planned work with minimum supervision to contribute to meeting business goals.
Normally requires a Bachelor Degree or may have a Master’s Degree from a four-year college or university
Typically has 6-8 years of directly related experience