Senior Manager, Design Quality Assurance - Medical Devices

sonova singapore pte. ltd.; Singapore; Híbrido; SGD 180.000 - 230.000; Jornada completa

Descripción de la vacante

Sonova Singapore Pte. Ltd. seeks a Senior Manager, Design Quality Assurance to lead the design QA team, guiding product launches and ongoing engineering.

You will ensure compliance with ISO 13485, ISO 14971, IEC 62304 and MDR 2017/745, maintain SOPs, CAPAs and post-launch activities through strong cross-functional collaboration.

Formación

• Proven experience leading design quality assurance in a regulated environment.
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304 and MDR requirements.
• Experience with medical devices, hardware and software development.

Responsabilidades

• Lead the Design Quality Assurance team in Singapore to ensure timely product launches and minimize deviations.
• Act as quality representative for design/development of medical devices (hardware and software).
• Coach team members and support post-launch engineering activities and CAPAs.
• Communicate project progress to the Department Manager and collaborate with stakeholders.
• Harmonize procedures and processes within the R&D organization to reduce redundancies.
• Support reliability improvements and ensure SOP alignment with regulations.
• Assist Process Owners with SOPs, process improvements, and post-launch changes.

Conocimientos

Leadership

Quality systems

Regulatory knowledge

Design Control

Cross-functional collaboration

Communication skills

Educación

Bachelor's degree in engineering or science

Master's degree (preferred)

Herramientas

Polarion

SAP

Descripción del empleo

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SONOVA SINGAPORE PTE. LTD.

Typically Replies in 30 Days

Senior Manager Design Quality Assurance

MCF-2026-1276172

INFINITE STUDIOS, 21 MEDIA CIRCLE 138562

Permanent

Senior Management

8 years exp

Engineering

$10,000 to $13,000 Monthly 19 applications Posted 24 Aug 2026 Closing on 23 Sep 2026

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CAPA

FMEA

Research & Development

Develop Standard Procedures

Organisational Alignment and Interdependency Analysis

ISO

Reliability Requirements

Process Flows

pre-launch activities

Team Coaching

Hardware and Software Support

Lead Project Teams

Collaboration With Stakeholders

Project Status Reporting

Product Improvement

Launch Planning and Management