Quality Manager

Hegen; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Hegen in Singapore is seeking a Quality Manager to lead QA across design, manufacturing and supplier quality for infant feeding products. You will implement ISO 13485-aligned QMS, drive CAPA, analytics and cross‑functional improvements with R&D, Production, Supply Chain and Customer Success.

You will mentor the quality team, manage audits, ensure product safety and regulatory compliance, and partner with manufacturing to reduce defects and improve yield in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Quality or equivalent.
• At least 5 years in manufacturing QA with plastics moulding.
• Experience implementing or auditing ISO 13485 QMS.
• Strong knowledge of SPC, FMEA and CAPA.

Responsibilities

• Develop, implement and maintain a QMS aligned with ISO 13485 and regulatory requirements.
• Oversee product quality across lifecycle from design to after-sales.
• Lead supplier quality management and audits; drive CAPA and corrective actions.
• Coordinate manufacturing quality controls across moulding, assembly and packing.
• Lead and develop the Quality team and drive Lean/Six Sigma improvements.

Skills

Quality management

ISO 13485

Lean Six Sigma

Root cause analysis

Stakeholder management

Leadership

Analytical thinking

Education

Bachelor's degree in Mechanical/Manufacturing/Quality or equivalent

Tools

QMS software

MS Office

SPC tools

Job description

Build quality that parents can trust.At Hegen, quality is at the heart of the products we create and the confidence families place in us. We are looking for a

Build quality that parents can trust.At Hegen, quality is at the heart of the products we create and the confidence families place in us. We are looking for a Quality Manager who combines strong manufacturing expertise with hands-on leadership to uphold the safety, reliability and consistency of our bottles and feeding products. You will lead quality across product development, supplier qualification, manufacturing and after-sales support, with a strong focus on manufacturing process controls and quality management systems aligned with ISO 13485 requirements. Working closely with R&D, Production, Supply Chain and Customer Success, you will prevent defects, resolve issues at their root and drive lasting improvements. If you enjoy taking ownership, developing people and working closely with manufacturing partners to turn quality standards into everyday practice, we would love to meet you.

Responsibilities

Quality Strategy & Governance

• Develop, implement and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485 requirements, applicable regulatory requirements and company objectives.
• Define and monitor quality KPIs across product development, manufacturing and supplier operations, using performance data to prioritise improvements.
• Champion quality ownership and adherence to established procedures across the organisation.
• Partner with senior leadership to align quality priorities with business strategy.

Product Quality Management

• Oversee quality across the product lifecycle, from design and development through production and after-sales support.
• Collaborate with R&D, Production, Supply Chain, Commercial and Customer Success to establish product quality specifications, acceptance criteria and testing requirements.
• Lead product evaluation, verification, validation and relevant certification activities to ensure products meet applicable safety requirements and internal quality benchmarks.
• Lead the investigation of product defects and customer complaints, driving root cause analysis and corrective and preventive action (CAPA), and verifying the effectiveness of implemented actions.
• Oversee the management of non-conforming products and product recalls, where required.
• Partner with design, engineering and production teams to address quality risks and improve product design and manufacturability.

Supplier Quality & Compliance

• Establish and maintain qualification, onboarding and audit processes for suppliers and manufacturing partners.
• Evaluate suppliers’ quality systems and manufacturing capabilities against Hegen’s specifications and applicable requirements.
• Monitor supplier quality performance and ensure timely resolution of supplier-related non-conformances.
• Drive supplier development initiatives to strengthen process capability, improve yield and reduce recurring defects.
• Maintain accurate supplier quality records, including certifications, audit findings and corrective action documentation.

Manufacturing & Operations Quality

• Work closely with Production, Operations and manufacturing partners to establish and maintain quality controls across moulding, assembly and packing processes.
• Oversee incoming material inspection, in-process inspection and finished product testing against defined specifications and acceptance criteria.
• Apply statistical process control (SPC) and other appropriate quality tools to monitor process performance and prevent defects.
• Ensure effective product identification, traceability and control of non-conforming materials and products throughout manufacturing.
• Oversee manufacturing process validation and the assessment of quality risks arising from changes to materials, tooling or processes.
• Lead internal quality audits and coordinate external audits against ISO 13485 and other applicable requirements, ensuring timely closure of findings.

Team Leadership & Continuous Improvement

• Lead and develop the Quality team, setting clear responsibilities, goals and performance expectations.
• Build an inclusive team environment that encourages learning, accountability and proactive problem-solving.
• Lead cross‑functional improvement projects using methodologies such as Lean, Six Sigma or Kaizen.
• Analyse quality data and customer feedback to identify trends, prioritise improvements and measure results.
• Evaluate and adopt technologies that strengthen quality monitoring, reporting and process efficiency.

Requirements

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Quality Management or a related discipline, or an equivalent qualification.
• At least 5 years of relevant experience in manufacturing quality assurance and quality management, with hands-on experience in plastic moulding and product assembly.
• Practical experience implementing, maintaining or auditing a QMS aligned with ISO 13485 requirements.
• Strong understanding of plastic materials, moulding processes, manufacturing process controls, defect analysis and product testing.
• Experience in process validation, traceability, non-conformance management, root cause analysis and CAPA.
• Proven track record in supplier quality management, manufacturing audits and process improvement.
• Familiarity with applicable product safety and regulatory requirements. Experience with infant feeding products or other products manufactured to stringent quality requirements would be an advantage.
• Proficiency in quality tools such as SPC, failure mode and effects analysis (FMEA) and structured root cause analysis.
• Demonstrated experience in leading and developing teams.
• Strong analytical, problem‑solving and decision‑making skills, with close attention to detail.
• Strong stakeholder management and communication skills, with the ability to influence internal teams and manufacturing partners.
• Strong organisational skills, with the ability to manage competing priorities in a fast-paced environment.
• Proficiency in quality management software and Microsoft Office applications.
• Ability to travel periodically to manufacturing facilities in Southeast Asia.

Who We Are

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.

Equal Opportunity & Data Protection Statement

Hegen is an equal opportunity employer and is committed to building an inclusive and diverse workforce. All employment decisions are based on merit, qualifications, and business needs. By submitting your application, you consent to the collection, use and disclosure of your personal data for recruitment and employment-related purposes in accordance with applicable data protection laws.

Join Us

At Hegen, we are passionate about fostering a purpose-driven, inclusive and collaborative work environment where every team member can thrive. We are 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 are inspired to make a difference and grow with a dynamic team, apply now and embark on an exciting journey with Hegen.