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Quality Assurance / Quality Engineering Specialist

Company: BioIntelliSense , Inc.
Location: Golden
Posted on: May 16, 2022

Job Description:

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 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 Responsibilities:

  • 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 validation.
  • 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 audit.
  • Maintain the company Approved Supplier List (ASL) by monitoring supplier qualification activities, leads initial evaluation and re-evaluation efforts.
  • 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 1.

      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 content.
      • 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 MDR
        • Experience and working knowledge of eQMS software Skills and Competence
          • High attention to detail with strong planning and organizational skills and experience managing multiple priorities simultaneously
          • Excellent oral and written communication and technical documentation
          • 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 collaboration
          • 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 embodies.
                • 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 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.PI174477469

Keywords: BioIntelliSense , Inc., Denver , Quality Assurance / Quality Engineering Specialist, Engineering , Golden, Colorado

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