QA Specialist

2 weeks ago

Singapore EVYD Technology Full time

We are EVYD Technology, a HealthTech company with a presence in Southeast Asia, the United States, and the Middle East.

Our vision is to build a future where everyone can access better health. Our products enhance the affordability, convenience, and availability of personalized healthcare.

What will you do?:


Our Regulatory Affairs team ensures all of our products are made with high quality standards and comply with regulatory standards for the healthcare industry.

As a Quality Assurance Specialist, you will establish and maintain quality assurance standards, review and revise QMS documentation, conduct employee quality training, and participating in nonconformance and CAPA processes.

Your expertise in risk assessment and experience in internal and external audits will contribute to maintaining our commitment to quality and regulatory compliance.

Join us and play a vital role in upholding our high-quality standards in the healthcare industry.

This role reports to our Regulatory Director and may be based in either Singapore or Beijing.

Your key responsibilities include:

  • Assist in establishing, maintaining, overseeing and enforcing all quality assurance standards and programs to assure compliance in accordance with ISO 13485, 21 CFR 820, IEC 6230
  • Initiate, revise and review controlled QMS documentation including procedures and reports.
  • Support Employee Quality Training design and delivery for companywide compliance. Promote a culture of quality and ensure compliance with SOPs in accordance with relevant regulatory standards.
  • Participate in nonconformance and CAPA identification, investigation, and resolution.
  • Maintain quality assurance and design control documentation with relevant stakeholders.
  • Participate in internal and external audits for the company.

Travel requirements:

Infrequent travel is required for this role. You may need to travel to China or Singapore in rare cases.

What skills do you need?:

Human skills:

  • Highly independent and selfmotivated and thrives in an ambitious and fastpaced environment.
  • Effective communication and collaborative skills to work closely with crossfunctional teams or stakeholders.
  • Ability to work with crossdepartmental functions including product manager, software developers, department leads, and other roles involved in QMS.
  • Possesses a growth mindset and is tenacious at completing set goals.
  • Strong analytical and problemsolving skills.
  • Highly organized with an exceptional sense of time management.
  • Acts with integrity and ethics.

Base technical skills:

  • Indepth knowledge of ISO 13485, IEC62304 and 21 CFR820.
  • Strong Skills in Medical Software QMS.
  • Proven experience in quality assurance for the whole software development lifecycle.
  • Demonstrated success in ISO13485 audit.

Qualifications:

  • Bachelor's degree or above in Computer Science, Engineering, or healthcare related fields
  • 3 years' experience working on the implementation and maintenance of medical software QMS. Experience working on Digital Therapeutics products is an advantage.
  • Ability to speak, read and write excellent English is required. The ability to speak good Mandarin to work with staff based in China is an advantage.

Why you should join us:

Make a meaningful impact
As one of the leading healthtech companies based in APAC. You will have the opportunity to directly impact the lives and wellbeing of individuals and communities.

Exciting growth opportunities
We offer an environment where you can make an impact and difference. Shape the future of our company, rather than being just a cog in one.

Collaborative and friendly culture
EVYD prides itself on its friendly and supportive work environment. Be a part of our close-knit teams that believe in working and playing hard together. We work with a global team to bring about the best of each culture.

Dynamic working environment


Have you ever found yourself sitting at your desk, staring at the clock, and waiting for the time to pass? At EVYD, we promise a dynamic environment where each day will whizz by.

You'll have opportunities to contribute to multiple functions and be deeply involved in growing our products and delivering excellence.

Personal and professional development
We are firmly committed to growing together with our people. We believe in growing the skills of our existing staff and giving them the chance to prove themselves. Where we lack, we hire the best to groom our next generation of leaders.

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