Talent.com
Quality Engineer
Quality EngineerHologic, Inc. • San Diego, CA, United States
Quality Engineer

Quality Engineer

Hologic, Inc. • San Diego, CA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Are you an aspiring quality professional looking to start or grow your career in the medical device industry? At Hologic, we are seeking a Quality Engineer to support validation efforts, risk management, and compliance within our Quality Management System. In this role, you’ll assist with process validations, equipment qualifications, and risk assessments while contributing to cross-functional teams for new product introductions and sustaining projects. If you’re detail-oriented, eager to learn, and excited to contribute to the delivery of life-changing healthcare products, we encourage you to apply and be part of our mission to improve lives worldwide!

Knowledge :

  • Foundational understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment / facility qualifications.
  • Basic knowledge of risk analysis techniques, such as PFMEA and process risk assessments.
  • Familiarity with regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
  • Awareness of change control processes and documentation requirements.
  • Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling methods.

Skills :

  • Ability to author and execute validation protocols, master validation plans, and reports under supervision.
  • Basic proficiency in electronic document management systems.
  • Strong technical writing skills to support regulatory submissions and controlled documents.
  • Ability to assist in maintaining validation records and evaluating process specifications.
  • Analytical and problem-solving skills to support quality investigations and process improvements.
  • Effective collaboration skills to work with cross-functional teams on New Product Introductions (NPI) and sustaining projects.
  • Organizational and time management skills to handle multiple tasks and meet deadlines.
  • Behaviors :

  • Detail-oriented and committed to maintaining accuracy and compliance in all tasks.
  • Proactive and eager to learn, with a willingness to take on new challenges in a regulated environment.
  • Collaborative team player, open to receiving feedback and contributing to shared goals.
  • Accountable and reliable, with a focus on timely communication and issue escalation.
  • Continuous improvement mindset, with an interest in optimizing processes and proposing enhancements.
  • Experience :

  • 0–2 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
  • Exposure to validation activities, including process validation and equipment qualification, is a plus.
  • Familiarity with Quality Management Systems and regulated environments preferred but not required.
  • Why join Hologic?

    We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

    The annualized base salary range for this role is $69,000-$101,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

    Agency and Third-Party Recruiter Notice

    Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

    Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

    #LI-NT1

    [job_alerts.create_a_job]

    Quality Engineer • San Diego, CA, United States

    [internal_linking.related_jobs]
    Quality Engineer

    Quality Engineer

    Abbott • San Diego, California, USA
    [job_card.full_time]
    Abbott 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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    Firestorm • San Diego, California, United States,
    [job_card.permanent]
    [filters_job_card.quick_apply]
    At Firestorm, we’re on a mission to revolutionize how defense solutions are designed and delivered.We call this vision “democratized deterrence. As a VC-backed company at the intersection of defense...[show_more]
    [last_updated.last_updated_variable_days]
    Quality Assurance Engineer

    Quality Assurance Engineer

    Reva Medical LLC • San Diego, CA, USA
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Summary of Essential Duties and Responsibilities.Provides technical engineering support to new and existing product development and sustaining engineering teams. Applies knowledge of manufacturing p...[show_more]
    [last_updated.last_updated_30]
    Quality Assurance Engineer

    Quality Assurance Engineer

    Leidos Inc • San Diego, CA, United States
    [job_card.full_time]
    Join a team committed to a mission!.We empower our teams, contribute to our communities, and operate sustainable.Everything we do is built on a commitment to do the right thing for our customers, o...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Validation Engineer (USC / GC / EAD)

    Quality Validation Engineer (USC / GC / EAD)

    Raas Infotek • San Diego, CA, United States
    [job_card.full_time]
    I have an immediate requirement, please let me know if you are interested in this role.Job Title : Quality Validation Engineer (USC / GC / EAD). Location : San Diego CA [ONSITE].Product software as a me...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Software Quality Engineer 2

    Software Quality Engineer 2

    Illumina • San Diego, California, USA
    [job_card.full_time]
    What if the work you did every day could impact the lives of people you know Or all of humanity.At Illumina we are expanding access to genomic technology to realize health equity for billions of pe...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Machine Learning Quality Engineer

    Senior Machine Learning Quality Engineer

    Servicenow • San Diego, California, United States
    [job_card.full_time]
    It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global market ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Design Quality Engineer 2

    Design Quality Engineer 2

    Illumina • San Diego, California, USA
    [job_card.full_time]
    What if the work you did every day could impact the lives of people you know Or all of humanity.At Illumina we are expanding access to genomic technology to realize health equity for billions of pe...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance Engineer

    Quality Assurance Engineer

    KYOCERA International, Inc. • San Diego, CA, United States
    [job_card.full_time]
    With nearly 80,000 employees globally, Kyocera is a leading manufacturer of high-tech ceramics in various industries, including aerospace, automotive, Medical applications, and semiconductor proces...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Engineer II, Risk Management

    Quality Engineer II, Risk Management

    Abbott • San Diego, California, USA
    [job_card.full_time]
    Abbott 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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Supervisor

    Quality Supervisor

    Jobot • San Diego, CA, US
    [job_card.full_time]
    Hands-on sheet metal fabrication company seeking a proactive, self-driven Quality professional.This Jobot Job is hosted by : Stephen Brainerd. Are you a fit? Easy Apply now by clicking the "Apply Now...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Operations Engineer

    Quality Operations Engineer

    Illumina • San Diego, California, USA
    [job_card.full_time]
    What if the work you did every day could impact the lives of people you know Or all of humanity.At Illumina we are expanding access to genomic technology to realize health equity for billions of pe...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Engineer, Hi-Rel

    Quality Engineer, Hi-Rel

    Blue Marble Communications • Poway, CA, USA
    [job_card.permanent]
    [filters_job_card.quick_apply]
    The Quality Engineer (QE) will be responsible for product compliance with internal and customer requirements.These spans conception to completion. In addition, the QE will develop, coordinate, impro...[show_more]
    [last_updated.last_updated_variable_days]
    Quality Systems Engineer

    Quality Systems Engineer

    Ignite Human Capital • San Diego, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    The Quality Systems Engineer plays a critical role in maintaining and improving the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.MDSAP, EU MDR 2017 / 745, ...[show_more]
    [last_updated.last_updated_variable_days]
    Quality Assurance Engineer

    Quality Assurance Engineer

    KYOCERA External • San Diego, California, USA
    [job_card.full_time]
    With nearly 80000 employees globally Kyocera is a leading manufacturer of high-tech ceramics in various industries including aerospace automotive Medical applications and semiconductor processing.O...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Engineer Hi Rel

    Quality Engineer Hi Rel

    T2S Solutions • Poway, California, USA
    [job_card.full_time] +1
    T2S Solutions company) is currently seeking to hire a.This role will be responsible for product compliance with internal and customer requirements spanning concept to addition the QE will develop ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Engineer ll

    Quality Engineer ll

    Innoflight LLC • San Diego, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    GROW WITH US AND STAY EXTRAORDINARY : .Launch your career to new heights with Innoflight—one of San Diego’s fastest-growing Aerospace and Defense innovators.Here, visionary minds eng...[show_more]
    [last_updated.last_updated_variable_hours] • [new]
    Quality Validation Engineer (USC / GC / EAD) (San Diego)

    Quality Validation Engineer (USC / GC / EAD) (San Diego)

    Raas Infotek • San Diego, CA, US
    [job_card.part_time]
    I have an immediate requirement, please let me know if you are interested in this role.Job Title : Quality Validation Engineer (USC / GC / EAD). Location : San Diego CA [ONSITE].Product software as a me...[show_more]
    [last_updated.last_updated_1_day] • [promoted]