Responsibilities:
- Perform internal calibration and verificationof measurement equipment in accordance with applicable standards (e.g., ISO 17025)
- Maintain and manage calibration schedules and records to ensure timely calibration of all relevant equipment. Investigate out-of-tolerance conditions and implement appropriate corrective and preventive actions (CAPA)
- Work with internal/external customers providing inspection, testing, process capability support, Qualifications/Validations, GRR, Minitab analysis, FAI analysis, and inspection plans in a timely manner
- Review and update work instructions associated with inspection techniques and inspection equipment. Work with Engineering to meet metrology needs
- Leads the nonconforming material and product processes which includes but is not limited to Disposition, Investigation, CAPA/Corrections and customer communication
- Key User and lead in ERP (Quality) and EQMS system
- Maintain and coordinate internal and external audits (ISO 13485)
- Support the quality methodologies for process changes. Support communication and process changes with the customer
- Provides training to others based on expertise, resume or demonstrated work experience. Uses training tracking system and ensures training requirements are up to date on a regular basis.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, customer returns, corrective actions, and re-validations
- Enhances department and organization reputation by accepting ownership for accomplishing new and different requests exploring opportunities to add value to job accomplishments
- Any other duties/projects assigned by management & Global Quality Team
Requirements:
- Bachelor of Science in any Engineering discipline
- Minimum 5 years of relevant experience in engineering or technical role
- Experience preferably in an ISO 13485:2016 and/or 9001:2015 work environment.
- Possess good knowledge on medical device knowledge.
- Ability to utilize MRP or ERP software and Statistical Analysis Software
- Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing experience
- Good understanding of metrology principles, measurement uncertainty, and calibration standards, with hands-on experience in equipment calibration and verification
- ASQ certified Quality engineer preferred
.We regret to inform that only shortlisted candidates would be notified
EA License Number
Vivian Chen
R23116467
EA 24C2366
