Senior Manager Design Quality Assurance

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 lifes 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 Sonovas 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:Bachelors degree in engineering science or quality with 10 years of relevant work experience (or a Masters 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 worlds leading hearing care providers headquartered in Switzerland were 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 candidates ethnic or national origin religion sexual orientation or marital status gender genetic identity age disability or any other legally protected status.