Quality Assurance / Quality Engineering Specialist
Company: BioIntelliSense , Inc.
Posted on: May 16, 2022
About the BioIntelliSenseBioIntelliSense is ushering in a new era
of continuous health monitoring and clinical intelligence for
Remote Patient Monitoring (RPM). Our medical-grade
Data-as-a-Service (DaaS) platform seamlessly captures
multi-parameter vital signs, physiological biometrics, and
symptomatic events through an effortless patient experience. The
FDA-cleared BioSticker--- and BioButton--- devices make remote
monitoring and early detection simple. Through the platform's
advanced analytics, clinicians, patients and employers will now
have access to high-resolution patient trending and reporting to
enable medical-grade care at home, and medical-grade screening in
the office, school, or residence. For more information on how
BioIntelliSense is redefining remote patient monitoring through
medical-grade and cost-effective data services, please visit our
website at BioIntelliSense.com. We are seeing hyper growth and
expanding our Regulatory and Quality Assurance team! We are looking
for an experienced Quality Assurance/ Quality Engineer Specialist
who is excited about joining a fast-paced startup and building
something great.About the RoleResponsible for the operation and
maintenance of the Quality Management System modules including but
not limiting to Document Control, CAPA, Complaint Handling,
Supplier Quality, and Audit Program. Responsible for planning,
conducting and monitoring testing and inspection of materials and
products to ensure design and finished product quality. Specific
- Author and maintain quality-related processes and detailed
procedures/work instructions within the company.
- Assist in training company personnel.
- Function as Document Control. Responsible for creating,
reviewing, and maintaining Quality Documents and Quality Records
per company's procedures. Processes change orders and initiates
associated training to new and revised procedures.
- Work with a multi-disciplinary team to obtain work-in-progress
technical documents (requirements and specifications) and finalize
them into formal and controlled design documentation
- Work with Engineering and Product Management, with basic
understanding of design of physical devices and software. Writes
test plans and protocols, conducts testing, and generates summary
reports to support product and process verification and
- Collaborate with operations and engineering teams to establish
quality standards and inspection plans for new and existing
products. Perform device testing or inspection and certifies
product release to customers; if testing identifies
non-conformance/ defect - also participates in the issue resolution
or design improvement process.
- Participate in customer complaint resolution, assessment, and
documentation. Lead the analysis of non-conforming materials and
returned goods. Recommend disposition and corrective actions.
- Support site compliance with requirements of FDA registration
and ISO 13485 certification.
- Lead site internal audits, and participates in inspection
preparation, resolution of audit and inspection findings, and
collaborates with auditing groups through all stages of the
- Maintain the company Approved Supplier List (ASL) by monitoring
supplier qualification activities, leads initial evaluation and
- Work with Company's domestic and overseas manufacturer on
creating, distributing, collecting, and reconciling the product
design and production documents and records
- Other duties as required by the Quality & Regulatory TeamYou're
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
reshapes the future of healthcare.
- Get the chance to work on cutting-edge technologies and use
world-class tooling to get the job done.
- Make a large impact across the company through business
deliverables and continuous innovation.
- Opportunity to build solutions and organizations from 0 to
What We're Looking ForRequired Experience:
- Bachelor's degree in biomedical engineering, other engineering
areas, or technology and science
- Experience in technical writing or documentation for technical
- Minimum 2 years working or project experience in Quality
Assurance, Quality Engineering, process Improvement or similar
discipline Preferred Experience:
- Experience in FDA regulations, ISO 13485 requirements, and EU
- Experience and working knowledge of eQMS software Skills and
- High attention to detail with strong planning and
organizational skills and experience managing multiple priorities
- Excellent oral and written communication and technical
- Task-oriented and ability to follow-up and close-up tasks in a
fast-paced work environment
- Ability to work independently, multitask and shift workload
according to department/ team priorities
- Strong interpersonal skills and multi-cultural/ intercultural
awareness; able to negotiate and build consensus for plans and
priorities and able to develop effective relationships through
- Working knowledge of Microsoft Office tools (e.g., Word, Excel,
PowerPoint) and PDF editor software Compensation
- $70,000-$90,000 (based on experience and location)Work Location
- This role will be onsite in either the Redwood City, CA or
Golden, CO officeWhy You'll Love Working at BioIntelliSense
- We are leaders - Leadership is not limited to our management
team. It's something everyone at BioIntelliSense embraces and
- We are doers - We believe the only way to predict the future is
to build it. Creating solutions that will lead BioIntelliSense and
the healthcare industry is what we do -- on every project, every
- We are learning - We're not afraid to dig in and uncover the
truth, even if it's scary or inconvenient. Everyone here is
continually learning on the job, no matter if we've been in a role
for one year or one minute.
- We have great benefits: Medical/Dental/Vision/Life (at little
to no cost to the employee), Disability (STD & LTD), 401(k)
matching, 10 Paid holidays a year, Generous vacation paid time
off**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.PI174477469
Keywords: BioIntelliSense , Inc., Denver , Quality Assurance / Quality Engineering Specialist, Engineering , Golden, Colorado
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