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Value Stream Quality Engineer

Align Technology
Align Technology (Ban Mu Thi 10 Moo 10, Pathum Thani, Thailand)
Pathumthani, Thailand 🇹🇭
Align Technology
We are dedicated to transforming lives by improving the journey to a healthy, beautiful smile. Discover your straight path to a bright future at Align Technology. As a part of our smart, diverse and fast-moving global team, you'll make an impact on the market leader that's moving an industry forward. Want to find out what's next for us—and for you? Follow us on LinkedIn for business updates and check out our current opportunities at www.aligntech.com/careers. 25 years ago, we pioneered the market for clear aligners. Since then, we have continuously innovated with new products and technologies that revolutionize treatments for doctors and their patients. Today, doctors and labs in over 100 markets use the Invisalign system, iTero intraoral scanners and exocad software to improve smiles for patients – from simple tooth alignment to complex corrections, kids to adults, orthodontics to multi-disciplinary restorative treatment.

Detail posisi

The Value Stream Quality Engineer will be responsible for supporting production and engineering in maintaining high compliance production processes and utilizing data to improve the iTero product line. This role will be based in Chonburi, Thailand.

Kewajiban

• Be a focal point for all quality issues in production, leading a treatment of quality issues, investigations, non-conformances, SCARs, internal communication, coordination, and trend analysis.
• Supervise ongoing quality requirements such as PFMEA, control plan, DMR/DHR, COC, COT, etc.
• Support equipment qualification for any HW/SW change.
• Ensuring production activities comply with GMP principles and satisfy quality standards such as 21 CFR Part 820, ISO 13485 etc. Ensuring all applicable worldwide regulatory requirements as included in the scope of Align’s quality manual related to production and process control.
• Provide employee training on quality issues regarding production processes.
• Provide input to applicable Align entities (Management, R&D, Logistic, customer success, etc.) derived from accumulated lessons learned from production processes.
• Drive Quality routine improvements that reduce failures rate, minimize failed-on Arrival/Install issues (DOA/RMA) and field failures, through in-depth evaluation of production processes.
• Assure Corrective and Preventive Action plans are developed and executed as a result of non-conformities and production processes analysis when applicable.
• Routinely Supervise production processes in all departments (such as assembly line, SMT lines, IQC) and follow up over corrective action and effectiveness verification.
• Interact positively in the most fruitful way with stakeholders regarding production processes. Among them are Production, Engineering, R&D, RA, complaints investigators, etc.
• Leading ongoing readiness for external audits.

Kualifikasi

• Fundamental knowledge of ISO13485:2016 and FDA requirements for medical device industry.
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
• Ability to work independently with minimal/remote supervision.
• Computer skills (Microsoft Word, Excel, PowerPoint).
• Working knowledge in