Sr. Quality Engineer

Natus Medical Incorporated Seattle , WA 98113

Posted 3 months ago

About Natus:

Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.

SUMMARY: Support new product development and design change activities for Natus products. Support the maintenance of quality system requirements, including internal and supplier auditing, Corrective and Preventive Action (CAPA), risk management, product and process issues, and provide general support of the quality system. Works on a wide range of quality issues related to Quality Systems, Product Quality, and Supplier Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Perform design quality engineering tasks.

  • Establish and update quality system procedures in compliance with requirements for medical devices

  • Participate in quality system audits in accordance with documented procedures.

  • Participate in Supplier Quality Management activities by conducting Quality audits for subcontract manufacturers and critical component suppliers

  • Support/maintenance of technical files, MDD certification and declarations of conformity in support of EU product registrations/CE mark.

  • Assists in the investigation and resolution of complaints.

  • Supports the CAPA system as a CAPA owner or team member.

  • Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.

Travel Required: minimal to moderate

Education and/or Experience:

Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, with a minimum of 5 years of experience in Quality Assurance / Engineering in an electro-mechanical medical device company. Current knowledge of FDA and international quality system requirements are a must.

Certificates, Licenses, Registrations:

Certification by ASQ as certified quality auditor (CQA) or quality engineer (CQE) is a preferred.

ISO 13485:2016 Lead Auditor certification is preferred.

Benefits:

Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually.

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

#LI-POST


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Quality Assurance Engineer TAA Tech

Amazon.Com, Inc.

Posted 3 days ago

VIEW JOBS 10/16/2019 12:00:00 AM 2020-01-14T00:00 Are you a QA specialist or quality-minded engineer who's up for a challenge? The Time & Attendance QA team supports solving test problems of optimization, performance, and scalability. Technologies we're testing range from 3rd-party platform configurations to API and front-end UI solutions. Do you want to write code, as well as test it? You'll immediately be given a chance to flex those muscles. Our automation needs are abundant and varied: dive into scenario-based employee data generation and API validation, canary and regression tests, and load test solutions. Are you a specialist in process? Join us as we evolve our deployment and custom agile development processes. Do you want a chance to Think Big? You'll be partnering with our dev and business teams teams to quantify and assure continuous infusion of quality, from requirements through user acceptance. Come be a key part of delivering a great user experience to Amazon employees all over the globe. Core responsibilities will include: * Implementing solutions to augment or replace manual tasks, infusing efficiency and metrics across the SDLC * Collaborating with dev and automation teams to identify and build tools that allow self-service testing of core functionality. * Gathering and reporting relevant and actionable quality metrics. * Enforcing, auditing, and streamlining software test and delivery processes. * Owning the role of Software Quality in project deliveries: from requirements analysis through test plan creation and execution. * Mentor junior engineers, so they can become as good as you are. Amazon.Com, Inc. Seattle WA

Sr. Quality Engineer

Natus Medical Incorporated