Consortium for Clinical Research and Innovation Singapore

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 We are looking for a highly experienced and detail-oriented Quality Assurance Manager to oversee and enhance our quality assurance strategies across all areas of operation. This leadership role is responsible for ensuring that our products, services, and internal processes consistently meet or exceed established quality standards, including those related to reliability, performance, and user satisfaction. The successful candidate will play a key role in fostering a culture of continuous improvement and operational excellence. You will lead initiatives to strengthen compliance with regulatory requirements, drive efficiency in quality systems, and elevate the overall customer experience. This is a pivotal role that requires a proactive mindset, strong leadership capabilities, and the ability to work cross-functionally to embed quality into every aspect of the business. KEY RESPONSIBILITIES Quality Strategy Develop and implement a comprehensive Quality Management System (QMS) aligned with company objectives, regulatory requirements, and industry best practices Define quality KPIs and metrics across product development and production. Monitor performance through regular reporting and audits Champion a culture of quality excellence and continuous improvement across all departments Partner with senior leadership to align quality goals with business strategy Quality Management Oversee quality product lifecycle from design and development to production and after-sales Collaborate with R&D, Commercial and Customer Success teams to define quality specifications, testing protocols, and compliance standards for new and existing products. Lead product evaluation, validation, and certification processes to ensure compliance with global safety standards and internal quality benchmarks. Oversee management of non-conformances, product recalls, and corrective/preventive actions (CAPA) to mitigate quality risks. Partner with design, engineering and production teams to drive root cause analysis and continuous improvement in product design and manufacturability. Regulatory, Compliance & Sustainability Develop, implement, and maintain the company's Quality Management System (QMS) in line with industry standards (e.g., ISO 9001, ISO 13485, GMP) Establish supplier qualification, onboarding, and auditing frameworks to ensure consistent adherence to quality, ethical and environmental standards. Conduct supplier performance reviews and collaborate on corrective action plans to resolve quality issues. Drive supplier development initiatives, fostering partnerships to improve process capability, yield, and reliability. Maintain up-to-date records of supplier certifications, compliance documentation, and audit results. Integratesustainabilityconsiderationsintoqualityframeworks,includingresponsiblesourcing,materialsafety,andwastereduction. Quality Operations Work with Production and Operations teams to ensure process control, traceability, and compliance throughout manufacturing. Implement in-process inspection, final product testing, and statistical process control (SPC) measures to ensure product conformity. Leadinternalaudits,managementreviews,andqualitygovernanceprocesses. Team Leadership & Continuous Improvement Champion a proactive, prevention-focused quality mindset throughout the organisation. Provide guidance, training, and coaching to teams to strengthen quality awareness and accountability. Support leadership with quality insights, reporting, and recommendations. WHAT WE ARE LOOKING FOR Bachelor's Degree in Mechanical Engineering, Quality Management and/or equivalent At least 5 years of relevant experience in quality management within a manufacturing or consumer goods environment. Knowledge in plastics manufacturing, plastics injection molding processes, defect analysis, and testing methods is highly preferred Deep knowledge of quality standards (e.g., ISO 9001, ISO 13485, GMP) and regulatory compliance framework Experience with audit processes and quality tools Excellent analytical, problem-solving, and decision-making skills Strong stakeholder management and relationship building skills Ability to drive cross-functional communications and influence outcomes in a fast-moving and dynamic environment. Detail-oriented and organized with an agile mindset Demonstrated experience in leading and developing teams Proficiency in using Quality Management software and Microsoft Office Suite Demonstrate commitment and responsibility to uphold high levels of quality standards and customer satisfaction Itisallaboutfosteringapurpose-driven, inclusive and collaborative work environment where every team member can thrive. At Hegen, you will find meaningful work, continuous learning opportunities and the chance to make a real impact. Joinusinrealisingourboldvisionofimpacting100millionmothersworldwidethroughinnovation,compassion,andexcellence.Ifyou'reinspiredtomakeadifferenceandgrowwithadynamicteam,apply now and embark on an exciting career with us!