全职 Quality System Engineer 工作, 薪水, Tecomet Pulau Pinang 公司招聘中 - Ricebowl

Position Summary

The Quality Systems Engineer I supports the administration, monitoring, and continuous improvement of the global QS program across all sites. This role ensures compliance with applicable standards, regulatory requirements, and internal procedures.

Principle Responsibilities

• Assist in maintaining and improving the QMS.
• Support compliance with FDA, ISO 9001, 13485, AS9100 and other applicable standards/regulations.
• Participate in document control activities and change control processes.
• Support all types of audits (external and internal).
• Support all phases of Corrective Action and/or Preventive Action (CAPA).
• Track and report on CAPA status.
• Assist, Support and Maintain risk management documentation.
• Support employee training compliance.
• Collect and analyze quality metrics (KPIs).
• Prepare reports on Audit results, CAPA trends, Customer complaints, Process performance.
• Support continuous improvement initiatives.
• Collaborate with Complaint Handling, Nonconformance, Audit, and Risk Management teams to ensure proper escalation and systemic issue evaluation.
• Support (as needed) in internal external audits.
• Contribute to harmonization and continuous improvement of global CAPA procedures and workflows.
• Support quality-related projects by working with manufacturing, engineering, regulatory, and operations teams.

Qualification Requirements

Credentials/Experience:

• ASQ Certified Quality Improvement Associate (CQIA)
• Six Sigma Yellow or Green Belt

Experience/Educational/Training Preferred:

• Bachelor's degree in Engineering, Quality, Life Sciences, Data Analytics, or related technical discipline required.
• Minimum of 1 years of experience in a regulated manufacturing environment (medical device preferred).
• Exposure to Quality Management Systems (QMS) and CAPA processes preferred.
• Basic understanding of FDA QSR (21 CFR Part 820), ISO 13485, or other regulated standards preferred.
• Experience working with data analysis and reporting tools such as Power BI (preferred), Tableau, or similar business intelligence platforms.
• Internship or project experience in quality analytics or process improvement is a plus.

Knowledge, Skills, and Abilities:

LANGUAGE SKILLS

• Ability to speak, read and write in English language and Bahasa Malaysia.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Working knowledge of SPC and Process Validations.

Technical Skills

• Basic knowledge of root cause analysis methodologies.
• Proficiency in Microsoft Excel (pivot tables, data analysis functions).
• Experience developing dashboards or visual reports using Power BI or similar tools preferred.
• Understanding of statistical concepts such as trend analysis, control charts, and basic risk prioritization.
• Strong data organization and reporting capability.