At Hegen, we redefine the parenting experience with award-winning innovations tailored for mothers and their little ones. As a trusted brand in mother and baby products, our mission is to empower mothers in their breastfeeding journey and ease the transition into parenthood through meaningful products and services. Recognized as one of Singapore’s top 10 fastest growing companies, Hegen takes pride in creating practical solutions that combine thoughtful designs with functionality and sustainability for time-strapped parents.
ABOUT THE ROLE
The Senior Quality Engineer will play a critical role in ensuring that Hegen’s products consistently meet highest quality and safety standards across the entire lifecycle, from design and development to production and distribution. The role involves implementing quality assurance strategies, driving continuous improvement initiatives through close collaboration with Commercial, R&D, Manufacturing, Supply Chain and other cross-functional teams.
This role requires technical expertise, analytical rigor, and strong customer insights to oversee complex quality challenges and guide both internal teams and suppliers toward best-in-class quality outcomes.
RESPONSIBILITIES
Quality Assurance & Control
- Lead quality assurance activities for new product development (NPI), ensuring compliance with Hegen’s quality standards, regulatory requirements, and customer expectations.
- Develop, implement, and maintain quality control plans, inspection protocols, and testing procedures for raw materials, components, and finished goods.
- Conduct root cause analysis for quality issues, drive corrective and preventive actions (CAPA), and monitor their effectiveness.
- Facilitate audits of production processes, suppliers, and contract manufacturers to ensure compliance with established standards and regulations (ISO 9001, ISO 13485).
Product Development Support
- Collaborate with R&D, manufacturing, and operations teams to integrate quality into new product introductions and process improvements.
- Review and approve product specifications, test plans, and validation protocols to ensure products meet functional, safety, and regulatory requirements.
- Support material and component qualification for new suppliers, including assessment of production capabilities and quality reliability.
Supplier Quality Management
- Partner with procurement and supplier teams to establish quality agreements, specifications, and inspection standards.
- Conduct supplier audits and performance assessments, providing feedback and driving continuous improvement
- Monitor supplier performance metrics and implement improvement plans for non-conformance or recurring issues
Continuous Improvement
- Identify opportunities for process improvement, cost reduction, and efficiency enhancement across the product lifecycle
- Lead or participate in cross-functional quality improvement projects using Lean, Six Sigma, or similar methodologies.
- Maintain and improve Hegen’s quality management system (QMS), ensuring alignment with industry standards and regulatory requirements
Compliance & Documentation
- Ensure compliance with relevant local and international regulatory standards (e.g., FDA, EU MDR, ISO, IEC standards for baby products)
- Maintain accurate and up-to-date quality documentation, reports, and records for internal audits and regulatory submissions
- Support internal and external audits, addressing findings and implementing corrective actions promptly
REQUIREMENTS
- Bachelor’s degree in Engineering, Quality Management, or a related technical field
- 5 to 8 years of experience in quality engineering or assurance within plastics manufacturing, consumer goods and/or medical products
- Experience with new product introduction (NPI) and cross-functional project management.
- Proven track record in supplier quality management, process improvement, and regulatory compliance.
- Strong knowledge of quality tools, methodologies, and standards (e.g., ISO 9001, ISO 13485, GMP)
- Strong analytical, problem-solving, and decision-making abilities.
- Attention to detail, structured, and methodical approach to managing complex quality challenges.
- Knowledge of international quality standards and regulatory requirements relevant to mother and baby products.
- 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 passionate about fostering a purpose-driven, inclusive and collaborative work environment where every team member can thrive. We’re committed to supporting personal growth and offering opportunities for career development at every stage of your journey.
Join us in realising 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 you!
Apply now to embark on an exciting career with Hegen! Alternatively, you may submit your resume and cover letter directly to careers@hegen.com.