Deskripsi Pekerjaan
Join Molnlycke as a Senior QA Engineer and take the lead in ensuring the highest quality standards for our manufacturing operations. In this critical role, you will spearhead customer complaint management systems and maintain end-to-end control of Non-Conformance (NC) and Corrective and Preventive Actions (CAPA) processes within our MasterControl platform. You'll collaborate with cross-functional teams to implement robust quality assurance protocols, drive continuous improvement initiatives, and ensure compliance with international standards. Molnlycke offers a dynamic environment where your expertise will directly impact product safety and customer satisfaction. This position requires a proactive problem-solver with a passion for excellence and the ability to mentor junior team members while maintaining meticulous documentation and reporting standards.
Tanggung Jawab
- Lead customer complaint management lifecycle from initial reporting to resolution closure
- Oversee end-to-end control of Non-Conformance (NC) documentation and workflow
- Manage Corrective and Preventive Actions (CAPA) processes within MasterControl system
- Develop and implement quality assurance procedures for manufacturing operations
- Conduct internal audits and ensure compliance with ISO/GMP standards
- Analyze quality data trends and recommend process improvements
- Train and mentor QA team members on best practices and regulatory requirements
- Prepare comprehensive quality reports for stakeholders and regulatory bodies
Kualifikasi
- Bachelor's degree in Engineering, Quality Management, or related field
- Minimum 5+ years of QA experience in manufacturing or medical devices
- Proficiency in MasterControl or similar quality management systems
- Strong knowledge of ISO 13485, GMP, and quality regulations
- Certified Quality Auditor (CQA) or equivalent qualification preferred
- Experience leading CAPA and Non-Conformance processes
- Excellent analytical and problem-solving skills with attention to detail
- Proven ability to document and maintain quality systems documentation