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Sr. Quality Engineer

Company: AliveCor, Inc.
Location: mountain view
Posted on: May 3, 2021

Job Description:

Quality Assurance Mountain View, California

Senior Quality Engineer

Making the invisible visible. By harnessing the power of artificial intelligence, we're advancing the practice of medicine for doctors and society. And we're just getting warmed up.

AliveCor, the creator of the Kardia Mobile ECG app, seeks a Senior Quality Engineer to join an early stage start-up that is changing the face of mobile health. In this role, you will be part of the Quality team responsible for ensuring that AliveCor products perform as intended and meet/exceed customer expectations. You will work closely with Regulatory, Engineering, Product Management, Operations, Clinical, and the Customer Service team to implement and maintain an ISO 13485 and FDA compliant Quality Management System. You will also work closely with AliveCors suppliers to continually improve the quality of AliveCor products. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you.

Responsibilities:

  • Assist new product development:
    • Represent Quality on new product development programs with key responsibility as being an internal advocate for exceptional customer experience through product quality, safety, design and reliability.
    • Serve as technical resource for requirements, risk, verification and validation, software, process validation, qualification of new equipment, reliability packaging, usability, etc.
    • Lead cross-functional risk management activities and product robust risk management file.
    • Maintain quality of design history file and ensure products are developed in compliance with FDA 21 CFR 820, MDD, ISO 13485, and AliveCors Design Controls procedures
    • Support regulatory submissions
    • Provide input to customer guides, online FAQs, etc. to improve customer experience.
  • Supplier Management:
    • Partner with Operations to monitor and continuously improve supplier performance.
    • Provide effective communication to suppliers regarding objectives, issues, and performance to KPIs
    • Perform/assist robust root cause investigations for issues and drive corrective actions, using appropriate failure analysis and statistical methods
    • Collaborate on changes to product and processes; ensure compliance to AliveCors Change Control process and provide technical support for assessment and execution of the change(s).
  • Lead or participate in Risk Management activities as required based on input from complaints data, including identification of new failure modes.
  • Initiate and execute CAPAs or NCs as needed.
  • Support quality and regulatory reviews, inspections, and audits as required.
  • Maintain and update quality system procedures
  • Maintain quality records and other controlled documents, internally and with suppliers
  • Promote a culture of quality throughout AliveCor
  • Other Quality duties as assigned
Requirements:
  • 5-7 years experience in the Medical Device (or other medically regulated) industry, preferably in Quality or Regulatory.
  • Bachelors degree in engineering, clinical sciences, related sciences, or relevant related experience.
  • 2-4 years experience considered with Masters degree in engineering, clinical sciences, related sciences, or relevant related experience.
  • CQE or equivalent certification, desired
  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as: FDA 21CFR Parts 803, 806 and 820, ISO13485, ISO14971, IEC62304, IEC60601, IEC62366, European Medical Device Directives and Canadian Medical Devices Regulation.
  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
  • Ability to manage small projects: organized, independent, and results-oriented.
  • Experience with implementation and maintenance of quality systems in a regulated environment.
  • Experience in communicating with engineering, other technical teams and management to collect product information, investigate product or process issues, conduct robust risk assessments, etc.
  • Experience in working with OUS suppliers or contract manufacturers is desired.
  • Demonstrated competence documenting technical information and communicating it to others.
  • Must have a positive attitude with excellent communication, negotiation, and interpersonal skills to maintain a team-oriented environment and develop critical relationships with contractor manufacturers and suppliers.

The Perks:

AliveCor is located in downtown Mountain View, CA. We are close to Caltrain and supply car and bike parking for employees. We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen.

  • 401(k) Matching
  • Flexible and generous vacation policy
  • Maternity / Paternity Leave
  • Generous Benefits - employee 100% covered for medical, dental and vision
  • Mobile reimbursement
  • Stocked kitchen + weekly catered lunches
  • A supportive, collaborative group of people who understand that success depends on the team

AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law.

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Keywords: AliveCor, Inc., Mountain View , Sr. Quality Engineer, Other , mountain view, California

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