Quality Engineer

4 weeks ago


Fremont, California, United States DivIHN Integration, Inc Full time
*Title: Quality Engineer*Location: Alameda, CA

Duration: 12 Months with possible extension

*A detailed description of the position will be shared once we get your application**Quality Engineer*Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 5-8 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
  • FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others. A wide degree of creativity and latitude is expected.
  • Typically reports to a manager or head of a unit/department.
  • Emerging Regulations team- manages regulations and works with cross function teams.
  • Regulations can be very narrow and specific. Analytical, proactive, communication skills, must do research and prep work to understand regulations before meetings with stakeholders.
  • Some documentation work - identify gaps in processes or product design.

Job Type:
Contract

Pay:
$ $47.00 per hour

Benefits:

  • Dental insurance
  • Health insurance
  • Life insurance
  • Referral program

Schedule:

  • Monday to Friday

Application Question(s):

  • Do you have regulatory affairs/ Quality Engineer experience?
  • Do you have medical device experience?

Work Location:
In person

  • Fremont, California, United States Qapel Medical Inc Full time

    Identify and support the qualificat i on of suppl i ers for materials needed for products.Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned manufacturing processes and related business continuity needs in production and to contract manufacturer as needed.Provide engineering expertise to the design, fabrication...


  • Fremont, California, United States Scribetx Full time

    at Scribe Therapeutics Alameda, California Our mission is to engineer best-in-class CRISPR therapies that will permanently treat the underlying cause of disease in vivo.Scribe uses holistic molecular engineering to design, evolve, build and apply exclusive CRISPR technologies with enhanced therapeutic attributes for in vivo use.Scribe Therapeutics is seeking...

  • Sr Algorithm Engineer

    4 weeks ago


    Fremont, California, United States ATR International Full time

    Job Description:We are seeking a Sr Algorithm Engineer for a very important client.we are looking for talented team members to help us deliver our advanced computer vision algorithms to tomorrow's intelligent video products Studying industry trends across deep learning and computer vision, we create new ideas and concepts for HDR tone mapping and low light...


  • Fremont, California, United States Lam Research Full time

    At Lam, as an Etch Product Engineer, you thrive in high-stakes, dynamic environment, driving product development at the forefront of the semiconductor equipment industry. Collaborating closely with customers and internal teams, you will provide real-time problem-solving to customer challenges and to enhance our products. You will lead and manage high profile...

  • Product Engineer 5

    4 weeks ago


    Fremont, California, United States Lam Research Full time

    Engineer innovative semiconductor equipment and process design solutions to quickly resolve customer issues and improve product quality in a dynamic fast-paced challenging environment. Lead product development projects from product prototyping, development, deployment/product release, and initial field support. Independently design and conduct experiments,...


  • Fremont, California, United States Amazon Full time

    AMZL Sr. Station Leaders are responsible for all budgetary, people development and operations objectives for an Amazon Logistics Delivery Station (DS). Additional responsibilities include managing and leading a team of Operations, Area and Shift Managers, coaching and mentoring the team to ensure performance objectives are met, building positive employee...

  • Quality Engineer

    1 week ago


    Fremont, United States Katalyst Healthcares and Life Sciences Full time

    Summary: Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements. Maintains the Quality System to comply with regulatory requirements. Leads continuous quality improvement activities. This is a hands-on position that works with Customers and all functions and levels within the company. Job Description: Quality...


  • Fremont, United States MASS Precision, Inc Full time

    Job DescriptionJob DescriptionAbout Us:MASS Precision Inc. is a global manufacturer with over 30 years of experience excelling in the custom contract manufacturer of electronic chassis, frames, fabrications, and turn-key electromechanical assemblies built to customer specifications.MASS manufactures medical devices and military electronics for some of the...


  • Fremont, United States Brooks Automation Full time

    At Brooks, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of World Class, Empowered, Accountable, Respectful, Engaged....


  • Fremont, United States Brooks Automation Full time

    At Brooks, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of World Class, Empowered, Accountable, Respectful, Engaged....

  • Quality Engineer II

    7 days ago


    Fremont, United States Confluent Medical Technologies Full time

    Work on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participate in decisions on scope of work, selection of equipment and length of tasks. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower level personnel. ESSENTIAL DUTIES AND...

  • Quality Engineer

    1 week ago


    Fremont, United States Katalyst Healthcares and Life Sciences Full time

    Summary: Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements. Maintains the Quality System to comply with regulatory requirements. Leads continuous quality improvement activities. This is a hands-on position that works with Customers and all functions and levels within the company. Job Description: ...


  • Fremont, United States Zoox Full time

    The Manufacturing Process Quality Engineer will ensure that all processes that are conducted as part of the assembly, bring-up, and End-of-Line (EOL) testing of our vehicles will meet the high-quality standard of Zoox. This includes the development and implementation of In-Line and End-of-Line quality checks as well as driving the root cause resolution of...


  • Fremont, United States Zoox Full time

    Zoox Quality Systems Engineer will report to the Manager, Quality Systems and have the final goal to support the development of business processes to ensure that Zoox's products and services provide a high level of quality that meets the defined standards and specifications and in the end, the customer expectations. You will be responsible for defining and...


  • Fremont, United States Zoox Full time

    Zoox Quality Systems Engineer will report to the Manager, Quality Systems and have the final goal to support the development of business processes to ensure that Zoox's products and services provide a high level of quality that meets the defined standards and specifications and in the end, the customer expectations. You will be responsible for defining and...


  • Fremont, United States Hyve Solutions Full time

    Quality EngineerHyve Solutions Corporation designs and delivers custom purpose-built Server, Storage, and Networking Solutions to the world's largest Cloud, Social Media, and Enterprise companies. Our products provide the best Total Cost of Ownership (TCO) to our customers by focusing on cost and energy efficient designs. Our customers are visionary in...


  • Fremont, United States Hyve Solutions Full time

    Quality Engineer Hyve Solutions Corporation designs and delivers custom purpose-built Server, Storage, and Networking Solutions to the worlds largest Cloud, Social Media, and Enterprise companies. Our products provide the best Total Cost of Ownership (TCO) to our customers by focusing on cost and energy efficient designs. Our customers are visionary in...


  • Fremont, United States Hyve Solutions Full time

    Quality EngineerHyve Solutions Corporation designs and delivers custom purpose-built Server, Storage, and Networking Solutions to the world’s largest Cloud, Social Media, and Enterprise companies. Our products provide the best Total Cost of Ownership (TCO) to our customers by focusing on cost and energy efficient designs. Our customers are visionary in...


  • Fremont, United States Hyve Solutions Full time

    Quality EngineerHyve Solutions Corporation designs and delivers custom purpose-built Server, Storage, and Networking Solutions to the world’s largest Cloud, Social Media, and Enterprise companies. Our products provide the best Total Cost of Ownership (TCO) to our customers by focusing on cost and energy efficient designs. Our customers are visionary in...


  • Fremont, United States Western Digital Full time

    Job Description Responsibilities include: Identifying and fixing weak links and bottlenecks in the production line, covering both process and equipment. Work on the fab floor of Fremont and Great Oaks fabs frequently with manufacturing and engineering teams to perform audits and fix issues. Proactively enhance the robustness and efficiency of wafer...

  • Quality Technician

    1 week ago


    Fremont, United States LanceSoft Full time

    Duration : 06+ monthsDescription: The Manufacturing Quality Engineering Technician will support the Manufacturing Engineering Team and work cross-functionally with Vehicle Engineering, Corporate Quality and Supplier Quality within. The Technician will use their technical background to perform root cause analysis on vehicles, record their findings, and...

  • Quality Manager

    3 weeks ago


    Fremont, United States SlingShot Connections Full time

    Job DescriptionJob DescriptionAs the Quality Manager, you will be responsible for overseeing all aspects of thequality management system to ensure compliance with regulatory requirements and customerexpectations. You will lead a team of quality professionals and collaborate with cross-functionalteams to drive continuous improvement initiatives and maintain...

  • Quality Manager

    14 hours ago


    Fremont, United States Evolve Manufacturing Full time

    Company Overview: Evolve is a leading contract manufacturer in the medical device industry, dedicated to producing innovative and high-quality medical devices. We are committed to exceeding customer expectations and maintaining the highest standards of quality and compliance. As we continue to expand, we are seeking a skilled and experienced Quality Manager...

  • Quality Manager

    7 hours ago


    Fremont, United States Evolve Manufacturing Full time

    Company Overview: Evolve is a leading contract manufacturer in the medical device industry, dedicated to producing innovative and high-quality medical devices. We are committed to exceeding customer expectations and maintaining the highest standards of quality and compliance. As we continue to expand, we are seeking a skilled and experienced Quality Manager...

  • Quality Manager

    1 hour ago


    Fremont, United States Evolve Manufacturing Full time

    Company Overview: Evolve is a leading contract manufacturer in the medical device industry, dedicated to producing innovative and high-quality medical devices. We are committed to exceeding customer expectations and maintaining the highest standards of quality and compliance. As we continue to expand, we are seeking a skilled and experienced Quality Manager...


  • Fremont, California, United States Western Digital Full time

    Job Description Responsibilities include: Identifying and fixing weak links and bottlenecks in the production line, covering both process and equipment. Work on the fab floor of Fremont and Great Oaks fabs frequently with manufacturing and engineering teams to perform audits and fix issues. Proactively enhance the robustness and efficiency of wafer...