Senior Quality Engineer

4 days ago

Santa Clara, California, United States Cirtec Medical Full time
Sr. Quality Engineer Job Description

Cirtec Medical Corporation is seeking a highly skilled Sr. Quality Engineer to join our team. As a key member of our quality team, you will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.

This role will focus on providing quality engineering support to the new product development process, operations/production, and quality systems. You will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

Key Responsibilities:
  • Provide Quality Engineering support for engineering product development and sustained manufacturing of catheters
  • Ensure quality requirements are communicated and met at suppliers
  • Review manufacturing records to perform lot release activity for catheters, including COC issuance
  • Provide Quality Project Management support as needed for product transfers from development to validation to production
  • Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination
  • Develop and maintain Standard Operating Procedures
  • Develop and maintain project Quality Plans for assigned projects
  • Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement
  • Lead the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols, and equipment calibration/maintenance to ensure compliance with the Quality System
  • CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures
  • Interact with customers and suppliers to resolve CAPA and complaint investigations
  • Provide Quality Support for the disposition of material via NCRs
  • Support supplier quality activities including supplier approval and maintaining and assessing supplier performance data (i.e. SCAR/on time)
  • Provide audit support for third party audits, customer audits and internal audits
  • Support the implementation of continuous improvement initiatives
  • Develop and maintain supplier control plans
  • Initiate and maintain SPC (Statistical Process Control) for production processes
  • Lead FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable
  • Complies with company, quality and safety standards, policies, and procedures
Requirements:
  • Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline
  • 5 years minimum experience in medical device environment, catheter experience preferred
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office
  • Must possess excellent verbal communication, organizational and management skills
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access. Minitab experience desirable
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
Pay Range:

The pay range for this role is $110,000 to $166,000. The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions.

Working Environment:

This is not a remote position. Work is performed in an office environment. The noise level in the work environment is usually moderate.

EEO Statement:

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law.

  • Senior Quality Engineer

    3 days ago

    Santa Clara, California, United States Cirtec Medical Full time

    Job Title: Senior Quality EngineerCirtec Medical is seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our engineering department, you will be responsible for developing and implementing quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.Key Responsibilities:Provide...

  • Senior Quality Engineer

    2 days ago

    Santa Clara, California, United States Cirtec Medical Full time

    Job SummaryThe Senior Quality Engineer will be responsible for developing and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This role will provide quality engineering support to the new product development process, operations/production, and quality systems.Key Responsibilities:Provide...

  • Senior Supplier Quality Engineer

    2 days ago

    Santa Clara, California, United States Actalent Full time

    Job Title: Senior Supplier Quality EngineerJob Description:The Senior Supplier Quality Engineer will play a key role in supporting manufacturing operations, including process validations and line transfer projects. This individual will also be responsible for managing suppliers and procurement, collaborating with cross-functional teams such as Manufacturing...

  • Senior Quality Assurance Engineer

    3 days ago

    Santa Clara, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.Job SummaryWe are seeking a highly...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States Pulivarthi Group Full time

    Job Title: Senior Quality Assurance EngineerJob Overview:We are seeking a highly experienced Senior Quality Assurance Engineer for a 12+ month contract role based in Santa Clara, CA. The ideal candidate will have over 10 years of experience and expertise in quality engineering (QE), specializing in automation tools for both UI and API testing.Key...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Santa Clara, California, United States Cambridge Recruiters Full time

    Senior to Principal Quality Engineer OpportunityWe are seeking a highly skilled Quality Engineer to join our team at a growing vascular device company in Santa Clara. The ideal candidate will have a strong background in Design Control, Risk Management, and Quality Management Systems.Key Responsibilities:Develop and implement quality control processes and...

  • Senior Software Quality Engineer

    2 days ago

    Santa Clara, California, United States Ab Ovo Full time

    Job Summary:Ab Ovo, Inc. is seeking a Senior Software Quality Engineer to join our team. The successful candidate will be responsible for ensuring the quality of our software products through automated testing, collaboration with development teams, and identification of defects.Key Responsibilities:Design and implement automated test scripts using Java and...

  • Senior Product Quality Engineer

    4 weeks ago

    Santa Clara, California, United States NVIDIA Full time

    Senior Product Quality EngineerNVIDIA is a leader in the technology industry, renowned for its innovative products and talented workforce. We are seeking a skilled Senior Product Quality Engineer to join our team, responsible for leading failure analysis efforts for our data center liquid-cool product segment.Key Responsibilities:Champion root cause debug...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Santa Clara, California, United States Nvidia Full time

    NVIDIA Job DescriptionNVIDIA is seeking a Senior Supplier Quality Engineer to join our team. As a key member of our Quality Engineering group, you will be responsible for developing and implementing world-class supplier quality programs for our AI-centric datacenter, automotive, and consumer products.Key Responsibilities:Manage end-to-end component quality,...

  • Senior Director of Hardware Quality and Compliance Engineering

    3 days ago

    Santa Clara, California, United States Palo Alto Networks Full time

    Job Title: Senior Director of Hardware Quality and Compliance EngineeringPalo Alto Networks is seeking an experienced and highly motivated Senior Director to lead our hardware quality and compliance engineering team. This role will be instrumental in ensuring our hardware products meet stringent quality standards, regulatory requirements, and customer...

  • Senior Software Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States ServiceNow Full time

    Job Title: Senior Software Quality EngineerAt ServiceNow, we're transforming the way organizations work. As a Senior Software Quality Engineer, you'll play a critical role in ensuring the quality of our software products.Key Responsibilities:Maintain and improve existing automation test frameworksCollect and analyze quality metrics from test...

  • Senior Director Hardware Quality and Compliance Engineering

    2 days ago

    Santa Clara, California, United States Palo Alto Networks Full time

    About the RolePalo Alto Networks is seeking an experienced and highly motivated Senior Director to lead our hardware quality and compliance engineering team. This role will be instrumental in ensuring our hardware products meet stringent quality standards, regulatory requirements, and customer expectations.Key ResponsibilitiesEnhance existing Quality...

  • Senior Quality Assurance Engineer

    2 days ago

    Santa Clara, California, United States Telenav Full time

    About the RoleWe are seeking a highly motivated Senior Quality Assurance Engineer to join our growing Auto team at Telenav. As a key member of our team, you will be responsible for ensuring the quality and reliability of our connected car and location-based platform services.Key Responsibilities:Review product requirements, user experience specifications,...

  • Senior Software Quality Assurance Engineer

    3 days ago

    Santa Clara, California, United States ServiceNow Full time

    Job Title: Senior Software Quality EngineerAt ServiceNow, we're transforming the way organizations work. As a Senior Software Quality Engineer, you'll play a critical role in ensuring the quality of our software products.Key Responsibilities:Maintain and improve existing automation test frameworksCollect and analyze quality metrics from test...

  • Senior Director Hardware Quality and Compliance Engineering

    2 weeks ago

    Santa Clara, California, United States Palo Alto Networks Full time

    About the RolePalo Alto Networks is seeking an experienced and highly motivated Senior Director to lead our Hardware Quality and Compliance Engineering team. This role will be instrumental in ensuring our hardware products meet stringent quality standards, regulatory requirements, and customer expectations.Key ResponsibilitiesEnhance existing Quality...

  • Senior Software Quality Assurance Engineer

    2 days ago

    Santa Clara, California, United States Exostellar, Inc. Full time

    We are seeking a highly skilled Senior Software Quality Assurance Engineer to join our team at Exostellar, Inc. The ideal candidate will have extensive experience in designing and implementing automated test frameworks for cloud-native applications, as well as a strong background in software engineering and testing methodologies.The successful candidate will...

  • Senior Quality Systems Engineer, FlashArray

    2 weeks ago

    Santa Clara, California, United States Pure Storage Full time

    Join Pure Storage's FlashArray TeamWe're seeking a highly skilled Senior Quality Systems Engineer to join our FlashArray team. As a key member of our engineering organization, you'll play a critical role in ensuring the highest quality of our storage solutions.Key Responsibilities:Plan, test, and qualify shipping releases to ensure the highest quality of our...

  • Senior Software Quality Assurance Engineer

    2 days ago

    Santa Clara, California, United States Nvidia Full time

    NVIDIA Job DescriptionWe are seeking a highly skilled Senior Software QA Test Development Engineer to join our team at NVIDIA. As a key member of our QA team, you will be responsible for ensuring the highest quality of our products.Key Responsibilities:Develop and execute test plans, cases, and scripts to validate product functionalityCollaborate with...

  • Senior Software Quality Assurance Engineer

    4 weeks ago

    Santa Clara, California, United States NVIDIA Full time

    About NVIDIANVIDIA is a world leader in GPU Computing, driving innovation in various markets, including gaming, automotive, professional vision, HPC, datacenters, and networking.We are passionate about harnessing the power of AI and deep learning to transform industries and improve lives.Job SummaryWe are seeking a Senior Software QA Test Development...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Sr. Quality EngineerShockwave Medical, Inc. is a pioneering company in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and...