changing lives.
This position will be based out in Chonburi, Thailand
In this role, you will…
- 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.
In this role, you’ll need …
- 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 Statistical Tools (Measurement Systems Analysis, Process Capability and Statistical Process Control)- preferred.
- Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc.
- Strong written and verbal communication skills in English.
- Strong organizational skills.
- Bachelor's Degree in an engineering or equivalent applicable experience.
- 3 years of experience in production quality processes preferable in medical device industry or highly regulated industry.
