Quality Assurance Engineer
Biofourmis is a rapidly growing, global digital health company filled with committed, passionate professionals who care about augmenting personalized care and empowering people with complex chronic conditions to live better and healthier lives. We are pioneering an entirely new category of medicine by developing clinically validated, software-based therapeutics to provide improved outcomes for patients, smarter engagement & tracking tools for clinicians, and cost-effective solutions for payers. We are collectively devoted to a single-minded idea: powering personally predictive care.
Our dynamic growth has been marked by quadrupled headcount in the last 12 months via both expansion & acquisition, yielding a global footprint with offices in Boston, Singapore, Bangalore, and Zurich. We are backed by prominent international venture capital investment & have cultivated relationships with worldwide healthcare stakeholders over the last 5 years. Our talented team features numerous PhD's in Data Science and Biostatistics, over 80 patents, prolific scientific publications, world-class systems, developers & engineers, and leaders in the clinical operations space.
Quality Assurance Engineer
The role is located at our Boston office and will also involve collaborating with our Singapore office. Biofourmis develops software as a medical device (SaMD) product that we believe will change healthcare. This role is key in ensuring that our products are built with the highest quality, are validated in the appropriate clinical setting, and that our Quality System ensures a continued excellence and commitment to our customers and their patients. This position works with minimum supervision and has appreciable latitude for implementing actions.
This is primarily a remote position in the Boston area where working from the Boston office will be required at times.
Responsibilities
Evaluate quality data including investigating complaints, nonconformances, and CAPAs. Drive for root cause understanding and corrective action implementation to ensure product meets requirements.
Monitor and ensure timely closure of US and OUS complaint/feedback and work with cross- functional teams on any potential reportable events.
Assist with hosting external audits from partnerships and regulatory authorities.
Contribute to the timely closure of audit findings.
Perform or assist with audits of US suppliers and manage supplier documentation.
Maintain clinical trial documentation, as needed, within the organization in accordance with
regulatory standards.
Ensure quality and regulatory requirements are met for all product distributed by Biofourmis in
the US.
Review documents that are submitted and maintained in Biofourmis's document and product
lifecycle management system adhering to GDP requirements.
Contribute to the successful completion of design transfer plans and qualification activities.
Author or review key component engineering lifecycle deliverables throughout product
development, as defined by procedures.
Track timelines and facilitating the required project deliverables.
Work independently to determine and develop efficient solutions that are thorough,
practicable, and consistent with organizational objectives.
Demonstrate ability to document test data, analyze test results utilizing statistics, write clear
and concise lab reports, and make recommendations to evaluate product.
Improve and update US specific SOPs or WIs.
Investigate nonconformances, complaints, and MDRs while ensuring their timely closure; and ensuring CAPAs are initiated, investigated, and effectively closed where applicable.
Maintain quality data including but not limited to nonconformances, complaints, MDRs, CAPA, training, and suppliers.
Ensure non-product software meets the requirements of 21 CFR part 11.
Communicate regularly with suppliers and support supplier management activities for the US by
ensuring audits are performed and records are current.
Review and approve design and quality documents.
Provide quality support for the Boston site, clinical, operations, R&D, and other departments.
Requirements
Preferred knowledge of and experience in ensuring medical devices are in conformance with ISO 62304 and 60601 requirements.
Preferred to have knowledge of industry privacy standard, such as HIPAA, GDPR, etc., and FDA cybersecurity guidance documents will be added advantage.
Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.
Good interpersonal skills; ability to work effectively in a team environment and build strong working relationships.
Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude.
Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.
Bachelor's degree in Science, Engineering, Regulatory or Medical Device, Pharmaceutical industry.
Minimum of 2-3 years of relevant experience, or advanced degree with relevant experience.
Preferred ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or
Regulatory Affairs Certification (RAC).
Knowledge of Quality System Regulations 21 CFR 820, ISO 13485, and ISO 14971.
Knowledge of IEC 62304 is preferred.
Knowledge of industry privacy standard, such as HIPAA, GDPR, etc., and a solid understanding of
FDA cybersecurity guidance documents will be added advantage.
Knowledge of medical device engineering standards, risk management, verification and validation.
By
Biofourmis
Augmenting personalised care with digital therapeutics so that: - PATIENTS do get affordable and effective health management - PROVIDERS do personalize and improve patient experience and quality of care, and - PAYERS do realize economic benefits...
2 jobs
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