索诺瓦
Senior Manager Design Quality Assurance
Senior Manager Design Quality Assurance
发布于 大约 14 小时前中层管理(经理/总监)
新加坡市
高级经验
全职员工
混合式弹性办公
本科
质量管理
SAP
FMEA
ISO 13485
ISO 14971
IEC 62304
Leadership
Risk Management
Design Quality Assurance
Mdr 2017/745
AI 估算 · 40k–70k
Senior manager role in medical device industry, Singapore location, requires 10+ years experience and regulatory expertise. Mark
职位详情
关于这个职位
This role leads the Design Quality Assurance team in Singapore, ensuring new products and sustaining engineering initiatives meet safety, effectiveness, and regulatory standards. You will drive quality throughout the product lifecycle, coach team members, and collaborate with global R&D to harmonize processes. The position offers a hybrid work model and opportunities for professional growth.
最低要求
· 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).
· In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and MDR 2017/745.
· Over a decade of experience in a regulated environment, preferably within the Medical Devices industry.
· Proven track record in Quality roles of increasing responsibility within large, multi-site, global organizations.
· 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.
· Self-confident, well-organized, reliable, with strong stakeholder management skills.
· Experience in leading teams and developing people.
· Professional proficiency in English (written and spoken).
· Advanced MS Office skills.
工作职责
· 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.
优先资格
· Familiarity with QMSR, MDSAP, ISO 9001, IEC 62366-1, and the EU AI Act is a plus.
· German language skills are a nice-to-have.
· Polarion and SAP experience being beneficial.
AI 洞察
优缺点分析
优点
- High impact role ensuring safety and effectiveness of life-changing hearing solutions.
- Strong career development support with individual development plans and training opportunities.
- Hybrid working model offers work-life balance flexibility.
- Global exposure working with cross-functional teams in a leading hearing care company.
- Significant responsibility for product quality and regulatory compliance, with high stakes.
- Need to stay updated with evolving regulations (e.g., EU AI Act) and manage complex documentation.
- Leading a team and driving process harmonization across a growing R&D organization can be demanding.
- This role is ideal for an experienced quality leader with deep medical device regulatory knowledge, who enjoys mentoring teams and driving process improvements in a global, hybrid environment.
缺点 / 挑战
暂无明显挑战项
角色解读
- Advance to Director of Quality or VP of Quality within a global medical device company.
- Broaden expertise into regulatory affairs, post-market surveillance, or quality systems management.
- Move into senior R&D or operations leadership roles leveraging quality management experience.
- You lead the Design Quality Assurance team, ensuring new products and engineering changes meet regulatory and quality standards.
- You act as the quality representative in product development projects, covering both hardware and software for medical devices.
- You coach and develop team members, and drive alignment of quality processes across global R&D sites.
- Deep knowledge of medical device regulations: ISO 13485, ISO 14971, IEC 62304, MDR 2017/745.
- Strong leadership and stakeholder management abilities to guide teams and collaborate across functions.
- Practical experience with design control, risk management (FMEA), and medical device development including SaMD.
- Excellent communication skills to explain complex regulations to non-experts
- MS Office proficiency.
申请策略
- Tailor your resume to explicitly match the 'More about you' section—use the same keywords.
- Research Sonova's products and recent innovations to show genuine interest during interviews.
- Emphasize your experience in design control, risk management, and medical device regulations (ISO 13485, ISO 14971, IEC 62304, MDR).
- Highlight leadership achievements: team development, process harmonization, and successful product launches.
- Showcase specific examples of how you improved quality processes or resolved compliance issues.
- Mention any involvement with AI in medical devices or SaMD projects.
- Familiarize yourself with the latest MDR updates and QMSR requirements if not already proficient.
- Learn about the EU AI Act and its implications for medical device software.
面试指南
- Use the STAR method: Situation, Task, Action, Result for behavioral questions.
- For regulatory questions: link your knowledge to practical implementation examples.
- For leadership questions: emphasize coaching, delegation, and stakeholder alignment.
- How do you ensure design control compliance across multiple product development projects?
- Describe a time you led a team through a challenging quality improvement initiative.
- How do you stay updated with changing medical device regulations and apply them?
- Tell us about your experience with software as a medical device (SaMD) and risk management.
- How do you balance speed to market with rigorous quality assurance?
职位点评
75
综合评分
Senior quality role in a global medical device company, strong developmental support, hybrid work, undisclosed but likely competitive compensation.
更适合这类人
This role suits candidates who prioritize career growth, meaningful work in healthcare, and a flexible hybrid work environment.
表现最好
成长发展
相对薄弱
薪资福利
薪资福利50
成长发展85
工作生活80
使命价值85
薪资福利
50较低
Salary is not disclosed and compensation details are absent from the JD, but the senior level and location suggest strong earning potential.
薪资信号未披露（AI估算：40K-70K/月）
福利待遇flexible hybrid working model、training opportunities、individual development plans
成长发展
85较高
The JD highlights training opportunities, career growth, and individual development plans, indicating strong developmental support.
技术前沿主流现代技术
技术栈ISO 13485、ISO 14971、IEC 62304、MDR、FMEA、Design Control、Risk Management
成长机会training opportunities、exceptional growth opportunities、individual development plans
业务类型ambiguous
工作生活
80较高
Flexible hybrid working model is explicitly offered, and Singapore location likely provides good work-life balance, though no specific remote days are stated.
工作模式混合式弹性办公
办公地点市区核心地段
加班情况未提及（无法判断）
工作生活平衡flexible hybrid working model
使命价值
85较高
The company's mission to bring sound to life and help millions highlights strong social impact, and the medical device industry is meaningful.
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号bring sound to life、help millions of people enjoy life's unforgettable moments
创新程度积极采用新技术
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