Quality Assurance Manager (f/m/x)

Ada Health

Ada Health

Quality Assurance
Germany · Berlin, Germany · United Kingdom · Remote
Posted on Thursday, January 18, 2024

ABOUT US

At Ada, we envision a world where everyone can access healthcare. In one of the world's biggest challenges, we pioneered a new form of artificial intelligence, combining medical knowledge with intelligent technology to empower millions of people to understand their health better. We’re proud to support medical doctors and work with leading health systems and global non-profit organizations. We’re a diversely skilled team representing 55 nationalities, and we’re growing rapidly to achieve our global ambitions for the future of health. This is just the beginning.

ABOUT THE ROLE

The Quality Assurance Manager works in Ada’s Compliance & Regulatory team and reports to the Quality Lead. They’ll help to manage and support Ada’s Quality Management Systems to ensure and maintain compliance, strategies, and objectives for our products, processes, and systems. They will ensure compliance with established quality assurance processes, standards, and global regulatory guidelines.

WHAT YOU WILL DO

  • Provide technical writing support to SOP owners and relevant stakeholders to ensure the quality of written processes

  • Ensure compliance with international regulations and standards

  • Provide training sessions (for ISO 13485, MDR, MDD and MPG, etc.) to relevant parties

  • Follow up and assist with routine management of audit action requests and corrective/preventive actions

  • Support quality management documentation for assigned product line(s) or processes; and identify and update failure modes and related process/product improvements by facilitating teams and implementing required changes

  • Support the verification, validation, monitoring ,and inspection of methods, procedures, and protocols specific to the assigned product line(s) and processes and production control(s)

  • Review nonconformance records (internal/external) to determine disposition, root cause and need for corrective and preventive

  • Enable and ensure Medical/Patient Safety team meets quality standards and regulatory requirements

  • Support preparation and execution of internal and external audits

  • Provide SME support to other functions to ensure end-to-end compliance at Ada

  • Support Supplier Management Process

  • Act as a proactive ambassador for Quality in all we do at Ada.

WHAT YOU WILL BRING

  • Minimum of a bachelor's degree in a relevant field, however a graduate degree is preferred

  • Previous QA experience that provides the knowledge, skills, and abilities to perform the job or an equivalent combination of education, training, and experience

  • Strong interpersonal, organisational, problem-solving and analytical skills; strong attention to detail

  • Knowledge of international and national regulations (i.e MDR, MDD, German MPG and MPSV)

  • Knowledge of ISO 13485, ISO 14971, EN 62304 or similar ISO norms regarding quality. Should have, or quickly obtain individual training and audit certifications for ISO 13485 and other related and relevant standards

  • Agile and Scrum knowledge and experience

  • Strong working knowledge of quality management systems and as support tools (e.g., Jira, Github)

  • Equivalent experience in a regulated industry

  • High level of written and spoken business English

  • Knowledge of the US FDA 21 CFR 820 (Quality Systems Medical Devices) is an asset

  • Technical background and knowledge of SDLC is an asset

  • Medical Device Experience is an asset

WHAT'S AWAITING YOU AT ADA

  • Join our global health mission to improve the health of billions of people around the world

  • Work in an international environment (55+ nationalities) and with medical doctors & and experts

  • Work with cross-functional & and diverse teams of smart, purpose-driven peers

  • Work wherever you feel most comfortable – home, office, or a bit of both

  • Receive financial support to help set up your home office space

  • Enjoy your country-specific vacation days to unplug, rest and recharge

  • Maintain a healthy work-life balance with our flexible working hours and locations

  • Meet and collaborate with colleagues via community days, virtual coffee chats, company parties, and team celebrations.

CONTACT

If you have any questions, please feel free to contact us at talent@ada.com.

Please note that we do NOT accept applications sent via email. All applications need to be completed using the online form.

All your information will be kept confidential according to GDPR guidelines.

*Any commercial activities concerning this advertisement will not be appreciated.