Sr. Quality Engineer
Company: AliveCor, Inc.
Location: mountain view
Posted on: May 3, 2021
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.
- 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
- Serve as technical resource for requirements, risk,
verification and validation, software, process validation,
qualification of new equipment, reliability packaging, usability,
- 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
- Supplier Management:
- Partner with Operations to monitor and continuously improve
- 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
- Collaborate on changes to product and processes; ensure
compliance to AliveCors Change Control process and provide
technical support for assessment and execution of the
- 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
- 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
- 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
- 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
- Must be able to work under pressure to meet regulatory
reporting time frames and company requirements.
- Ability to manage small projects: organized, independent, and
- 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,
- 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.
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
- 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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