Quality Assurance Director Job Vacancy in BioIntelliSense , Inc. Golden, CO 80401 – Latest Jobs in Golden, CO 80401

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Company Name : BioIntelliSense , Inc.
Location : Golden, CO 80401
Position : Quality Assurance Director

Job Description : Description:

About BioIntelliSense
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). We are seeing hyper growth and expanding our Quality team! We are looking for people who are excited about joining a fast-paced company and building something great.
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.
Our headquarters is located at the foothills of the Rocky Mountains near historic Golden, Colorado with an additional office located in Northern California (Redwood City).

About the Role
As Director of Quality Assurance, you will serve in a leadership role that is responsible for defining and promoting a quality mindset across the company. Responsible for establishing and maintaining the BioIntelliSense Quality Management System (QMS) to ensure it is in full compliance with all FDA regulations for for medical device manufacturers as well as ISO 13485:2016. Reporting to the Vice President of Quality and Regulatory, you will build and effectively lead the QA team.
This role will manage all activities relating to and will be responsible for:
Ensuring the effectiveness and efficiency of the QMS through day-to-day operation
Ensuring conformance with Company Policies and SOPs
Establish standards in coordination with Operations, Engineering, and Regulatory for new product testing, certifications, and disposition of products
Manage training systems and curriculum, ensuring compliance
Performing and Managing Quality System activities including but not limiting to:
Documents and records management and controls
Supplier control and supplier management
Support on any on-going testing and validations
Incoming, servicing, and fulfillment inspections
Design controls and design change controls and assessment
Management of the non-conformance and CAPA system
Complaint handling process including intake, assessment, investigation, and adverse event reporting
Internal audit and management reviews
Supporting Operations and Regulatory activities including any cross-funtional project teams
Guiding and mentoring QA resources
. Requirements:

What We Are Looking For
Bachelors in engineering or similar, appropriate domain is required, Master’s degree is desirable
Engineering degree in software engineering or computer science is a plus
8+ years of experience in medical device industry in a Quality Assurance role
A minimum of 2 years of experience in a leadership/ management role with a proven ability to lead teams through positive influence
Certified ISO 13485:2016 lead auditor is desirable
Proven experience in successful establishment and operation of QMS in a medical device company
Hands-on experience with key QA activities
Familiar with design and development process for software as medical device (SaMD)
Experience with startup / early stage companies
Experience with Greenlight Guru or similar QMS systems
Results-oriented, with an ability and flexibility to manage multiple projects simultaneously
Strong written and verbal communication skills, including ability to distill and communicate complex information
Ability to execute in a fast-paced environment
Uncompromising with respect to quality in all regards
Team player, good listener and capable of building strong relationships
Enthusiasm, high energy, and mind-blowing determination to succeed
Proven problem solver and ability to build and lead a successful team
Self-starter, able to work independently or in a team environment
Unquestionable integrity and ethics
Compensation: $100,000-$130,000 (based on experience and location)
Work Location: This role will be onsite in our Golden, CO office.
You’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 1.
Why 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 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 – on every project, every day.
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.
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