Quality Manager

HEGEN PTE. LTD.; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Hegen is seeking a Quality Manager who blends manufacturing expertise with hands-on leadership to uphold safety, reliability and consistency of our bottles and feeding products. You will lead quality across development, supplier qualification, manufacturing and after-sales, focusing on process controls and QMS aligned with ISO 13485.

Work with R&D, Production, Supply Chain and Customer Success to prevent defects, drive root-cause corrective actions and continuous improvements.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Quality or equivalent.
• 5+ years in manufacturing quality assurance with plastics moulding and assembly.
• Experience implementing or auditing ISO 13485 QMS.
• Knowledge of plastics materials, moulding processes, process controls.
• Experience with CAPA, root cause analysis, traceability, and non-conformance management.
• Supplier quality management and manufacturing audits.
• Familiarity with product safety and regulatory requirements; infant feeding products preferred.
• Proficiency in SPC, FMEA, and data analysis.
• Strong leadership, communication and stakeholder management.

Responsibilities

• Develop and maintain a QMS aligned with ISO 13485 and regulatory requirements.
• Define and monitor quality KPIs across development, manufacturing and suppliers.
• Lead quality across product lifecycle from design to after-sales.
• Collaborate with R&D, Production, Supply Chain, Commercial and Customer Success to set specs and testing.
• Lead product evaluation, verification, validation and certification activities.
• Conduct root cause analysis and CAPA; manage recalls if needed.
• Lead internal audits and coordinate external audits; ensure timely closure of findings.
• Lead and develop a Quality team; foster learning and accountability.
• Drive cross-functional improvement projects (Lean/Six Sigma/Kaizen).

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 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.

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, embark on an exciting journey with Hegen.