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| 勤務地 | マレーシア, Pulau Pinang |
| 雇用形態 | 正社員 |
| 給与 | 経験考慮の上、応相談 |
We are seeking a dynamic and experienced Quality Manager to take ownership of our Quality and Environmental Management Systems. In this high-impact role, you will drive compliance, operational excellence and continuous improvement, while partnering with stakeholders across the organization to ensure the highest standards of quality, regulatory compliance and customer satisfaction.
Job Descriptions
Serve as the appointed Quality Management Representative (QMR) and Environmental Management Representative (EMR).
Lead and maintain the company's Quality Management System (QMS) and Environmental Management System (EMS), ensuring compliance with ISO standards, regulatory and customer requirements.
Manage all QA and QC activities to ensure product quality and operational effectiveness.
Monitor, analyze and report quality performance, non-conformities, corrective actions and improvement initiatives to Management.
Plan, coordinate and lead internal audits, management review meetings and external certification audits.
Manage supplier/vendor qualification, assessment and performance monitoring programs.
Liaise with customers, certification bodies and relevant stakeholders on quality-related matters, including contract reviews and quality requirements.
Drive quality awareness, customer focus and continuous improvement initiatives across the organization.
Job Requirements
Bachelor's Degree or Master’s Degree in Chemical Engineering, Quality Engineering, or related engineering discipline.
Minimum 8-15 years of experience, preferably in the medical device, healthcare or related regulated manufacturing industry.
Strong knowledge and hands-on experience in ISO 13485, ISO 9001 and ISO 14001 management systems.
Certified Internal Auditor/Lead Auditor with experience leading and participating in third-party audits.
Proficient in quality management tools, quality control techniques and continuous improvement methodologies.
Strong leadership, analytical, problem-solving and stakeholder management skills.
Excellent communication skills with the ability to engage customers, auditors and cross-functional teams.
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| 職務経験 | 6年以上 |
| キャリアレベル | 中途経験者レベル |
| 英語レベル | 流暢 |
| 日本語レベル | 無し |
| 最終学歴 | 短大卒: 準学士号 |
| 現在のビザ | 日本での就労許可は必要ありません |
| 雇用形態 | 正社員 |
| 給与 | 経験考慮の上、応相談 |
| 業種 | その他(メーカー) |