QA Manager
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
QA Manager
The QA Manager is responsible for establishing implementing and maintaining effective quality compliance systems to ensure adherence to applicable regulatory requirements and AB Quality Systems requirements. The role coordinates quality management activities across departments at the AB China location supports new product introductions and product launches from a quality perspective and ensures quality system readiness for market operations.
This position is also responsible for driving the continuous improvement of the Quality Management System (QMS) including conducting and overseeing audits of policies procedures and operational processes to ensure ongoing compliance and effectiveness. Key responsibilities include management of document control processes oversight of adverse event reporting and complaint handling facilitation of risk assessments and collaboration with cross-functional teams to maintain product quality and operational compliance.
You will be base in Shanghai.
More about the role:
- QMS & Compliance: Establish and maintain the China Quality Management System (QMS) in full compliance with Chinese regulations (including GSP) and global company policies. Serve as the designated Quality Responsible Person.
- Process & Documentation: Develop optimize and control quality procedures work instructions and documentation to ensure alignment with regulatory standards and business needs.
- Supply Chain Oversight: Manage qualification auditing and performance reviews for suppliers distributors and third-party logistics (3PL) providers to ensure compliant storage and distribution.
- Market Surveillance & Risk: Monitor product quality lead complaint investigations manage adverse event reporting execute product recalls and generate post-market risk evaluation reports.
- Product Launch & Audits: Review packaging labeling and IFUs for compliance; support new product introductions; and lead responses to regulatory inspections (e.g. NMPA) and internal audits.
More about you:
- No less than 5 years experience in medical device QA with Bachelors degree or above (QRP related degree)
- Chinese as mother tongue. English fluent in both written and spoken.
- Able to travel when business needed.
- Problem solver and team player.
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.
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From hearing aids to cochlear implants to wireless communication, we are committed to offering the most c ... View more
