Quality Assurance Engineering (QA/QE) Specialist
Company: Biointellisense
Location: Redwood City
Posted on: October 16, 2024
Job Description:
Early Detection Made SimpleDenver, CO based ., 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.Salary 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.
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Keywords: Biointellisense, Modesto , Quality Assurance Engineering (QA/QE) Specialist, Engineering , Redwood City, California
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