Senior Manager Design Quality Assurance

sonova singapore pte. ltd.; Singapore; On-site; SGD 180,000 - 230,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Quality systems

Regulatory knowledge

Design Control

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in engineering or science

Master's degree (preferred)

Tools

Polarion

SAP

Job description

Who we are

You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Senior Manager, Design Quality Assurance

This position is to direct and guide the Design Quality Assurance team to not only introduce new products but also sustain engineering initiatives via the reliability team.

This leadership role ensures that our products are safe, effective, and launched in alignment with Sonova's design control requirements and protocols. The goal is to maintain the highest standards of product quality while satisfying market compliance regulations

More about the role:

• Lead the Design Quality Assurance team in Singapore, assigning members to project teams to ensure products are launched according to plan and process deviations are minimized.


• Act as the quality representative for design and development activities of medical devices, encompassing both hardware and software, and directly participate in development projects.


• Actively coach team members and provide career development assistance, while ensuring the effective execution and documentation of Post-Launch Engineering activities.


• Communicate project progress and status to the Department Manager and ensure effective collaboration with various stakeholders.


• Establish a homogeneous understanding of necessary procedures, processes, and approaches within the group R&D, driving the alignment and harmonization of processes in a growing R&D organization to eliminate redundancies and standardize where feasible.


• Support product improvements, particularly regarding reliability (e.g., supporting FMEAs), and ensure consistency of owned SOPs with internal and external regulations.


• Support the Process Owners with the creation and maintenance of SOPs, perform process improvements, and assist with open CAPAs, Post Launch Changes, and NCs as required.

More about you:

• Education:Bachelor's degree in engineering, science, or quality with 10+ years of relevant work experience (or a Master's degree with 8+ years of experience).


• Regulatory Knowledge:In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and MDR 2017/745. Familiarity with QMSR, MDSAP, ISO 9001, IEC 62366-1, and the EU AI Act is a plus.


• Experience:Over a decade of experience in a regulated environment, preferably within the Medical Devices industry. You have a proven track record in Quality roles of increasing responsibility within large, multi-site, global organizations.


• Technical Skills:Practical experience with Design Control, Product Risk Management, and Medical Device Development (including software like SaMD). Understanding basic AI functionality and its associated risks in medical devices is essential.


• Personal Attributes:You are self-confident, well-organized, reliable, and possess strong stakeholder management skills. Your ability to understand and explain complex device quality regulations to non-experts is excellent.


• Leadership:Experience in leading teams toward challenging but achievable goals and a commitment to developing and motivating people.


• Language & IT:Professional proficiency in English (written and spoken) is required; German language skills are a nice-to-have. Advanced MS Office skills are a must, with Polarion and SAP experience being beneficial.

More about what we offer:

As one of the world’s leading hearing care providers headquartered in Switzerland, we’re committed to building an inclusive culture. We want to create an environment where you can balance a successful career with your commitments and interests outside of work, through our flexible hybrid working model. We offer a wide range of training opportunities for both your professional and personal development, and there are exceptional growth opportunities with individual development plans.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the marketplace. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

Sonova is an equal opportunity employer.