Advanced Quality Systems Professional
3 days ago
As a key member of the quality assurance team, you will play a pivotal role in ensuring that our products meet the highest standards of quality and regulatory compliance.
The ideal candidate will possess a strong background in quality systems and a deep understanding of the medical device industry.
You will be responsible for implementing and maintaining product inspection and release processes, maintaining compliance with country-specific labeling processes, managing and tracking quality holds, and driving improvements for 3PL quality management systems and agreements.
Additionally, you will coordinate rework activities and internal complaints, perform first article inspections, ensure warehouse compliance with procedures and work instructions, and manage and follow up SCARs.
In this role, you will also act as quality engineer for APAC labeling and quality documentation, maintain supplier qualifications and support new supplier onboarding, provide supplier quality training and implement supplier control processes.
Furthermore, you will maintain product complaint handling processes in APAC, execute field corrective actions as local FCA coordinator, generate quality system reports and trend analysis, and maintain regional training compliance.
Requirements:
- Min. Bachelor's Degree in a related field.
- Minimum 5 years' experience in quality/manufacturing within the medical device industry.
- Strong knowledge of ISO 13485 and regulatory requirements.
- Proficient in MS Office Suite.
- Strong communication, problem-solving, and critical thinking skills.
- Knowledge of medical device or pharmaceutical documentation regulations.
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