Siti Wijaya
+62-812-4567-8901 | siti.wijaya@email.com | Jalan Merdeka 42, Jakarta Selatan, Indonesia | linkedin.com/in/sitiwijaya

PROFESSIONAL SUMMARY

Results-driven Senior Director of Quality Assurance with 15+ years of progressive leadership experience in manufacturing and quality management. Proven track record of implementing enterprise-wide quality systems, driving continuous improvement initiatives, and leading cross-functional teams to achieve operational excellence. Expert in GMP compliance, Lean Six Sigma methodologies, and organizational transformation. Demonstrated success in reducing defect rates, optimizing supplier quality programs, and establishing robust quality frameworks that support business growth and regulatory compliance.

PROFESSIONAL EXPERIENCE

Senior Director, Quality Assurance
PT Precision Manufacturing Indonesia, Jakarta
January 2020 – Present

• Lead global quality assurance organization of 85+ professionals across multiple manufacturing sites, establishing strategic quality vision and driving culture transformation initiatives that improved employee engagement scores by 42%
• Implemented comprehensive Advanced Product Quality Planning (APQP) framework that reduced product launch defects by 68% and accelerated time-to-market by 5 months across 12 new product introductions
• Spearheaded enterprise-wide Lean Six Sigma program resulting in $8.7M annual cost savings through waste elimination, process optimization, and statistical process control implementation
• Established supplier quality management system covering 200+ vendors, reducing incoming material defects by 54% and improving supplier scorecards through rigorous verification and validation protocols
• Directed cross-functional teams in root cause analysis and corrective/preventive action (CAPA) initiatives, achieving 98% on-time closure rate and reducing recurring quality issues by 73%
• Championed organizational design restructuring that streamlined quality operations, eliminated redundancies, and improved decision-making speed by 35%

Director, Quality Assurance & Compliance
Industri Berkah Sejahtera, Surabaya
March 2016 – December 2019

• Managed quality assurance department of 45 professionals responsible for ensuring GMP compliance and product quality across three manufacturing facilities
• Developed and executed quality management system that achieved zero FDA 483 observations during three consecutive regulatory inspections
• Led Failure Mode and Effects Analysis (FMEA) workshops that identified and mitigated 150+ potential quality risks, preventing estimated $4.2M in potential losses
• Implemented SAP-based quality management module, digitizing complaint management, change control, and deviation tracking processes with 99.2% data accuracy
• Established key performance indicators (KPIs) dashboard providing real-time visibility into quality metrics, enabling data-driven decision making across leadership team
• Directed packaging engineering quality initiatives that reduced packaging-related complaints by 61% through enhanced functional specifications and validation protocols

Quality Assurance Manager
Teknologi Maju Indonesia, Bandung
June 2012 – February 2016

• Supervised team of 18 quality professionals managing daily quality control operations, inspection activities, and compliance documentation
• Implemented business process mapping initiative that identified 23 process improvement opportunities, resulting in 28% reduction in quality inspection cycle time
• Led cross-functional innovation management projects that balanced quality requirements with product development timelines, supporting launch of 8 new product lines
• Developed comprehensive training program on statistical process control and quality improvement methodologies, certifying 120+ manufacturing personnel
• Managed complaint management system processing 2,000+ customer complaints annually with 96% resolution rate within SLA targets
• Coordinated loss prevention initiatives through enhanced quality controls, reducing scrap and rework costs by $1.8M annually

Senior Quality Engineer
PT Solusi Kualitas Terpadu, Medan
August 2009 – May 2012

• Executed verification and validation protocols for manufacturing processes and equipment, ensuring compliance with quality standards and regulatory requirements
• Conducted root cause analysis investigations using 8D methodology, implementing corrective actions that reduced process variation by 41%
• Collaborated with materials science team to qualify alternative raw materials, achieving $650K annual cost savings while maintaining product quality specifications
• Supported organizational development initiatives by mentoring junior engineers and leading quality training sessions for production personnel
• Participated in continuous improvement projects utilizing Lean Six Sigma tools, contributing to facility-wide quality culture transformation

Quality Engineer
Pabrik Standar Nasional, Tangerang
May 2007 – July 2009

• Performed quality control inspections and testing activities ensuring product conformance to specifications and customer requirements
• Developed and maintained quality documentation including work instructions, inspection plans, and control plans
• Supported change control process by reviewing engineering changes and assessing quality impact
• Participated in supplier quality audits and vendor qualification activities
• Analyzed quality data trends and prepared reports for management review

EDUCATION

Master of Science in Quality Assurance
Universitas Indonesia, Jakarta
Graduated: 2007

Bachelor of Science in Materials Science and Engineering
Institut Teknologi Bandung, Bandung
Graduated: 2005

CERTIFICATIONS

• Certified Quality Engineer (CQE) – American Society for Quality
• Lean Six Sigma Black Belt
• Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• ASQ Certified Quality Auditor (CQA)

CORE COMPETENCIES

Quality Management Systems | GMP Compliance | Advanced Product Quality Planning | Lean Six Sigma | Statistical Process Control | Root Cause Analysis | CAPA Management | Supplier Quality Management | Change Control | Complaint Management | FMEA | Process Improvement | Cross-functional Team Leadership | Organizational Strategy | Culture Transformation | Business Process Mapping | Verification & Validation | SAP Quality Module | KPI Development | Manufacturing Excellence | Packaging Engineering | Innovation Management | Organizational Leadership