Quality Assurance Specialist - Medical Devices
: Job Details :

Early Detection Made Simple™Denver, CO based BioIntelliSense, Inc., founded in 2018, is an award-winning continuous health monitoring and clinical intelligence company. Our market acceleration and expansion are driven by world-class executive management and a dedicated team of engineers, data scientists, commercial and operational professionals, which collectively harness decades of expertise in virtual care innovations, wearable sensor development, remote connectivity solutions and successful program execution. With these distinctive capabilities and proprietary continuous Remote Patient Monitoring (cRPM) technologies, BioIntelliSense is uniquely poised to transform care delivery from in-hospital to home.The FDA-cleared and award-winning BioButton® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through the platform's AI-driven analytics, clinicians have access to high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care. Join the BioTeam today and create a new standard of continuous care that delivers clinical value, economic benefits and operational efficiencies for providers, patients and caregivers globally! About The RoleThe Quality Assurance Engineering Specialist (QA/QE) will play a pivotal role in maintaining and enhancing our quality management system, ensuring compliance with regulatory standards, and supporting the production of safe and effective medical devices. You will work closely with cross-functional teams to drive quality improvement initiatives and address issues in a proactive and strategic manner.What You'll Be Doing

• Responsible for supporting the operation, maintenance, and improvement of the Quality Management System modules including but not limiting to Document Control, Complaint Handling, Audit Program, and Corrective Action and Preventive Action (CAPA).
• Quality Management System (QMS):
• Support the maintenance of the QMS and compliance with FDA and international regulatory requirements (e.g. ISO 13485).
• Conduct internal audits to evaluate and improve adherence to the QMS processes.
• Quality Processes:
• Identify opportunities for process improvement and drive initiatives to enhance product quality, reduce defects, and streamline operations.
• Implement best practices and tools for process control and improvement.
• Own individual CAPAs, drive and follow through CAPA investigations and actions with other teams.
• Documentation and Record Keeping:
• Input and update documents and records using electronic QMS software.
• Maintain accurate and organized records of quality documentation, including design and development, validation, calibration, change control, and customer feedback.
• Customer Feedback and Complaint Management:
• Investigate and analyze customer complaints, working closely with other departments to determine root causes.
• Implement corrective and preventive actions to address identified issues and prevent recurrence.
• Use customer feedback data to drive continuous improvement in product quality and customer satisfaction.
• Maintain risk assessment and risk management files.
• Other
• Other duties as required by the Quality & Regulatory Team.

What You Need

• Required:
• Bachelor's degree in biomedical engineering, other engineering areas, or technology and science.
• Minimum 2 years working or project experience in Quality Assurance, Quality Engineering, process Improvement or similar discipline.
• Experience in FDA regulations and ISO 13485 requirements pertaining to medical devices.
• Experience and working knowledge of eQMS software (examples: Greenlight Guru, Master Control).
• Excellent communication, teamwork, and problem-solving skills.
• Proficiency in Microsoft Office Suite, particularly Excel for data management and analysis.
• Ability to learn and adapt to new software and technologies quickly.
• Preferred:
• Experience in software validation
• Experience in risk management activities
• Basic understanding of data analysis tools and techniques.

$70,000 - $130,000 a yearSalary Expectations: Listed comp is total compensation and is based on experienceWork Location: Hybrid - Redwood City, CAYou'll be excited about this opportunity because you will:- Join a fast-growing company and grow right along with us- Work on challenging and interesting tech problems which reshape the future of healthcare- Get the chance to work on cutting-edge technologies- Make a large impact across the company through business deliverables and continuous innovation- Opportunity to build solutions and organizationsWhy You'll Love Working at BioIntelliSenseWe are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do.We are learning - We're not afraid to dig in and uncover the truth, even when it's inconvenient. Everyone here is continually learning on the job.We have great benefits - Medical/Dental/Vision/Life, disability (STD & LTD), 401(k) auto contribution program, 11 paid holidays per year, generous paid time off and a weekly lunch perk.BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.