Talent.com
Senior Quality Engineer
Senior Quality EngineerSonendo Inc • Laguna Hills, CA, US
Senior Quality Engineer

Senior Quality Engineer

Sonendo Inc • Laguna Hills, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description

Job Description

Sonendo, Inc. is a medical technology company with a unique mission to lead the transformation of dentistry through Sound Science®. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.

Applications accepted starting 11 / 17 / 25. The deadline to apply is subject to change. To apply, please submit your application through job boards, our company website, or call (949) 766-3636 for assistance.

Essential Duties and Responsibilities :

The Senior Quality Engineer will be responsible for the effective design and manufacture of medical devices, compliance with internal procedures and external regulations, and the efficient execution of business activities thereto related. The Senior Quality Engineer will be expected to :

  • Monitor and ensure compliance to internal quality system and external industry regulations
  • Provide quality support to determine process improvements, lead investigations, root cause analyses, corrective action, implementation activities and interface with all cross functional departments and / or suppliers to increase product quality.
  • Provide technical expertise regarding validations, verification and qualifications
  • Perform investigations for NCMRs, SCARs, and CAPAs
  • Participate in Risk Management activities ensuring compliance with ISO 14971, including but not limited to the completion of FMEAs, Risk Assessments, and Risk Management Plans / Reports.
  • Develop and maintain inspection and quality control procedures
  • Lead Supplier Management activities, including the execution of supplier qualifications and supplier audits
  • Ensure compliance with design control procedures
  • Maintain and develop procedures related to product realization and internal processes
  • Manage and mentor quality technicians, providing guidance on quality control techniques, processes and procedures.
  • Perform related duties as assigned by supervisor.
  • Maintain compliance with Quality System procedures and company policies

Education and / or Work Experience Requirements :

  • B.S. in Engineering, Life Science or related discipline required
  • Minimum of 5 years work experience in a regulated industry required (medical device preferred)
  • Minimum of 4 years work experience in quality engineering or quality assurance role
  • Working knowledge of 21 CFR Part 820, ISO 13485 pertaining to class II / class IIb medical devices
  • Demonstrated knowledge of statistical methods and principles
  • American Society of Quality Certified Quality Engineer (ASQ CQE) or Certified Medical Device Auditor (CMDA) a plus
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard practices
  • Physical Requirements :

  • Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and / or quantitative productivity standards.
  • Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
  • Must be able to lift and carry up to 25 lbs
  • The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
  • Must be able to remain in a stationary position for 50% of the time.
  • Must be able to occasionally move about inside the office to access file cabinets, office machinery, etc.
  • The ability to observe details at close range (within a few feet of the observer).
  • Compensation and Benefits :

    We pay competitively. The base salary range for this position is $103,000 – $126,400, depending on experience, qualifications, and location. Additional compensation such as annual or commission bonuses may be available.

    Full-time employees are eligible for a comprehensive benefits package including medical, dental, vision, HSA, FSA, life, disability, 401(k), CA paid sick leave, and paid time off. Additional company-sponsored benefits, such as parental wage replacement and Employee Assistance Program (EAP), will be discussed upon hire.

    Sonendo, Inc. fosters a collaborative, innovative workplace where every team member’s ideas contribute to our success.

    We are an Equal Opportunity Employer.

    No recruiters, please.

    [job_alerts.create_a_job]

    Senior Quality Engineer • Laguna Hills, CA, US

    [internal_linking.similar_jobs]
    Senior Engineer

    Senior Engineer

    Aria Group Inc • Irvine, CA, US
    [job_card.full_time]
    Automotive, Design and Development.Base salary will vary depending on job-related knowledge, education, skills, experience, and business needs. Salary is just one component of our comprehensive comp...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Quality Assurance Engineer

    Senior Quality Assurance Engineer

    TP-Link Systems Inc. • Irvine, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Headquartered in the United States, TP-Link Systems Inc.The company is committed to delivering innovative products that enhance people’s lives through faster, more reliable connectivity.With a comm...[show_more]
    [last_updated.last_updated_30]
    Senior Quality Engineering Manager

    Senior Quality Engineering Manager

    Design West Technologies, Inc. • Tustin, CA, US
    [job_card.full_time]
    With a commitment to excellence and innovation, we specialize in designing, manufacturing, and delivering high-performance solutions for our clients worldwide. Our team comprises passionate professi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Engineer

    Quality Engineer

    MRINetwork Jobs • Ontario, CA, US
    [job_card.full_time]
    Quality Engineer SQE – Automotive - Stamping and Assembly.IMMEDIATE NEED - QUALITY ENGINEER WITH AUTOMOTIVE EXPERIENCE.Join a Growing Automotive & Consumer Products Manufacturer!.Full ben...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Engineer I

    Quality Engineer I

    Sunrise Systems • Irvine, California, United States
    [job_card.full_time]
    [filters_job_card.quick_apply]
    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with interna...[show_more]
    [last_updated.last_updated_30]
    Senior Quality Engineer - AS9100 Required

    Senior Quality Engineer - AS9100 Required

    Higher Talent Group LLC • Irvine, CA, US
    [job_card.full_time]
    Senior Quality Engineer - Irvine, CA.Our Client is a global provider within a wide range of areas, including but not limited to aerospace and defense platforms, automation and manufacturing, and th...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Engineer

    Quality Engineer

    Venture Hire Group LLC • Irvine, CA, US
    [job_card.full_time]
    Quality Engineer (Irvine, CA) $95-110K+.Looking to join a cutting edge medical device team that is paving the way in a very unique product line? Read on! The Quality Engineer will be responsible fo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Engineer

    Quality Engineer

    Thermal Structures • Corona, CA, US
    [job_card.permanent]
    The Quality Engineer will interface with the factory teams supporting first article inspections, source inspections of production parts and become a DSQR / DQR for various primes.The Quality Engineer...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Engineer

    Quality Engineer

    OrthAlign Inc. • Irvine, CA, US
    [job_card.full_time]
    Smart Technology, growing medical device company, has an immediate opening for a Sustaining Quality Engineer II to provide expertise of our commercially launched Class II medical device product lin...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Principal Quality Engineer

    Principal Quality Engineer

    DIALITY INC • Irvine, CA, US
    [job_card.full_time]
    Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease.Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connect...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr. Quality Engineer

    Sr. Quality Engineer

    Endress + Hauser • Rancho Cucamonga, CA, United States
    [job_card.full_time]
    At Endress+Hauser, progress happens by working together.As the global leader in measurement instrumentation, our ~17,000 employees shape the future in the field of process automation.Whether develo...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Quality Engineer - Start Your Engineering Career!

    Associate Quality Engineer - Start Your Engineering Career!

    MCP Services • Corona, CA, US
    [job_card.full_time]
    Now Hiring : Associate Quality Engineer – Start Your Engineering Career Now!.Are you a recent engineering graduate ready to launch your career in quality and manufacturing? We’re looking...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Quality Engineer

    Senior Quality Engineer

    Jobot • Irvine, CA, US
    [job_card.full_time]
    Senior Medical Device Quality Engineer / Senior Sustaining Quality Engineer Needed for Growing Medical Device Company!.This Jobot Job is hosted by : Reed Kellick. Are you a fit? Easy Apply now by cli...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Engineer, R&D

    Senior Engineer, R&D

    Spyglass Pharma • Aliso Viejo, CA, US
    [job_card.full_time]
    At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives.We aim to achieve this ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Supplier Quality Engineer

    Supplier Quality Engineer

    Western Digital • Irvine, CA, US
    [job_card.full_time]
    At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. At our core, Western Digital is a company o...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Control Engineer

    Quality Control Engineer

    Rand Technology, LLC • Irvine, CA, US
    [job_card.full_time]
    The Quality Control Engineer (QCE) works closely with QC Inspectors, Sales, Purchasing, Quality, Compliance, and Customers / Vendors when necessary. In this role, the QCE provides technical support to...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Quality Engineer

    Quality Engineer

    Gentex Corporation • Rancho Cucamonga, CA, US
    [job_card.full_time]
    At Gentex Corporation, we’ve created an environment where great ideas and great people can thrive.Leveraging a history that spans over 130 years, Gentex is a global leader in personal protect...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Staff Quality Engineer

    Staff Quality Engineer

    Terran Orbital Corporation • Irvine, CA, US
    [job_card.permanent]
    Join a team where your impact reaches beyond the stars! At Terran Orbital, you're not just part of the system – you're a vital force propelling our mission forward.As trailblazers in ...[show_more]
    [last_updated.last_updated_30] • [promoted]