Deskripsi Pekerjaan
Join our innovative team as a Staff Engineer, IPQA, where you'll spearhead transformative quality assurance initiatives that define industry standards. This strategic role empowers you to architect robust QA frameworks ensuring process stability, risk mitigation, and regulatory excellence across complex engineering systems. You'll collaborate with cross-functional teams to implement cutting-edge quality methodologies, driving continuous improvement and operational excellence. Your leadership will directly influence product integrity, compliance adherence, and customer satisfaction in a dynamic global environment.
As a key technical authority, you'll conduct in-depth risk assessments, develop comprehensive validation protocols, and mentor engineering teams in quality-first principles. The position offers unparalleled opportunities to shape organizational quality culture while addressing emerging challenges in regulatory landscapes and technological advancements. If you're passionate about engineering excellence and possess the acumen to transform quality from a process into a competitive advantage, this role offers a platform to make significant impact.
Tanggung Jawab
- Design and implement enterprise-wide Quality Assurance strategies ensuring process stability and operational excellence
- Lead cross-functional risk mitigation initiatives through proactive quality planning and defect prevention
- Ensure regulatory compliance by developing and maintaining rigorous quality control frameworks aligned with industry standards
- Conduct comprehensive quality audits and root cause analyses to drive continuous improvement
- Collaborate with R&D and manufacturing teams to integrate quality-by-design principles
- Develop and maintain quality metrics dashboards for real-time performance monitoring
- Mentor engineering staff in quality methodologies and best practices
Kualifikasi
- Bachelor's degree in Engineering, Quality Assurance, or related technical field; advanced degree preferred
- Minimum 8+ years of progressive QA experience in regulated industries (medical devices, pharma, or manufacturing)
- Expertise in risk management frameworks (FMEA, HACCP, ISO 13485/9001)
- Proven track record implementing automated quality control systems
- Deep knowledge of regulatory requirements (FDA, EMA, ICH guidelines)
- Certification in Six Sigma Black Belt or equivalent quality methodology
- Strong analytical skills with proficiency in statistical process control tools