Manager, Quality Systems at Biofourmis
Biofourmis is a fast-growing digital health startup that is reinventing remote patient monitoring for post-acute cardiac care. By harnessing the power of artificial intelligence, we’re advancing the practice of medicine by detecting personalized patterns predictive of patient’s health deterioration. Named as “Top 20 Hottest Startups in Singapore” by Singapore Business Review and “Asia’s most Innovative Start-up” by Galen Growth Asia, Singapore, our team is powered by the passion of their mission to improve the lives of cardiac patients and those that care for them.
The Sr. Manager, Quality Assurance will provide leadership to maintain and improve the Company’s Quality System. You will act as the Deputy Management Representative and maintains expertise in applicable Quality System, ISO and FDA Regulatory requirements for the Company. This position plays a key strategic role in regulatory compliance, training and developing Quality objectives and metrics. The ideal candidate will provide knowledge and experience to Quality Engineering, Supplier Quality and Complaint Handling issues in the Company while supporting Engineering, Operations, Corporate Compliance, Customer Service and Medical/Clinical Affairs.
Provide regulatory compliance experience/knowledge to facilitate resolution of quality management system issues
Serve as a focal point for Quality matters, including corrective action and continual improvement activities
Formulate and recommend policies, strategies, tactics, goals and objectives relating to Quality and regulatory compliance
Assist and counsel executive management on Quality matters
Serve as a resource for statistical information in the Quality and Engineering areas
Foster awareness of Quality and Regulatory compliance
Assume overall responsibility for the effectiveness and compliance of the Quality Management System including the Quality Policy and Quality Manual
Perform all Deputy Management Representative responsibilities and facilitates Management Reviews
Present executive management with an executive summary of the Quality System metrics during Management Reviews, including Quality System and/or product improvement recommendations
Where appropriate, facilitate the non conformance process, CAPA activities, supplier quality, complaint handling and audit program to meet all procedural and regulatory requirements
Ensure the effectiveness, execution and timeliness of Internal Audits. Report the results to executive management during Management Reviews
Facilitate external audits from outside agencies
Prefer BSME or equivalent experience in a medical device environment
Thorough knowledge of 21 CFR 820 Quality System and ISO 13485 regulations.
Five or more years Quality Engineering experience in a medical device manufacturing environment preferred
Minimum two years Quality management/supervisory experience
Excellent written and verbal communication skills including ability to communicate technical information
Thorough knowledge of quality and reliability design principles
Prefer experience with software design, development, verification and validation
Proficient in analyzing product data to perform statistical and trend reporting
Familiar with inspection/test development
Preference for Certified Quality Engineer (CQE)
We try to make your life at work as smooth as possible, and offer a long list of benefits to make that happen.
Competitive salary and performance based incentives
Equipment allowance to build your ideal workspace
Stocked kitchen + weekly catered lunches
A supportive group of people who understand that success depends on the team
Our pace is fast and agile - we thrive in a highly dynamic work environment where independence, risk, and generative thinking are embraced and encouraged.
At Biofourmis, we have developed a new approach to remote monitoring to bring this extremely demanding goal within reach by making sense of biosensors, thereby providing continuous physiological insights anywhere, anytime. Biofourmis was founded by scientists, and cardiologists focused on combining clinicians’ knowledge of biological mechanism that drives the human body and diseases and advanced machine learning techniques to enable the machine find personalized patterns predictive of patient’s health deterioration. We do patient care differently and we are changing healthcare one patient at a time. How might you ask? By hiring the right talented data scientists, developers, clinicians and healthcare leaders to provide the patient with cutting edge tools to enable the best level of care and intervention at the right time.