Senior Quality Engineer

3 days ago

Singapore Hegen Full time

Direct message the job poster from Hegen About the Role The Senior Quality Engineer plays a key role in driving product and process excellence across the organization. This role is responsible for leading quality initiatives, ensuring compliance with industry standards and regulatory requirements, and championing a culture of continuous improvement. The Senior Quality Engineer partners closely with cross-functional teams to resolve complex quality challenges and enhance operational efficiency. Responsibilities Lead the planning, execution, and monitoring of quality engineering processes across the product lifecycle. Develop, implement, and maintain quality standards, procedures, and best practices to ensure compliance with industry regulations and customer requirements. Oversee root cause analysis and corrective/preventive action (CAPA) processes for critical issues. Conduct thorough risk assessments, validation protocols and reliability testing strategies to identify potential quality issues and ensure product safety and reliability. Drive quality risk assessments, validation protocols, and reliability testing strategies. Collaborate with R&D, manufacturing, and operations teams to integrate quality into new product introductions and process improvements. Mentor and guide junior engineers and quality associates, fostering technical growth and knowledge sharing. Analyze quality metrics and data trends to identify systemic issues and propose sustainable solutions. Serve as a subject matter expert (SME) in audits, inspections, and regulatory reviews. Develop and implement robust quality control plans for new product launches, ensuring that all quality requirements are met throughout the product development lifecycle. Stay up to date with relevant regulatory requirements and industry standards and ensure compliance with all applicable laws and regulations. Requirements Bachelor's degree in Engineering, Quality Management, or a related technical field 5–8 years of experience in quality engineering, preferably in manufacturing and/or medical devices Strong knowledge of quality tools, methodologies, and standards (e.g., ISO 9001, ISO 13485, GMP). Proven experience in root cause analysis, risk management, and process validation. Excellent problem-solving, analytical, and collaboration skills. Effective communicator with the ability to influence and drive change across teams. Adaptable and versatile in a dynamic and quality-driven environment At Hegen, we are deeply passionate about building a purpose-driven, inclusive, and collaborative workplace where every team member is empowered to thrive. We believe in nurturing personal growth, providing meaningful challenges, and creating opportunities for career advancement at every stage of your journey with us. Join us in realizing our bold vision of impacting 100 million mothers worldwide through innovation, compassion, and excellence. If you're inspired to make a difference and grow alongside a dynamic team, we would love to hear from youApply now to embark on an exciting career with Hegen. Alternatively, you may submit your resume and cover letter directly to . #J-18808-Ljbffr

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