Sr. Quality Engineer

Found in: beBee jobs US - 2 weeks ago


Portola Valley, California, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities :


Perform quality activities related to the IVD development activities which includes providing guidance for design controls, risk management, change control, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.

Provide guidance on stability testing, sample plan definition, process validation study, and design transfer documentation to ensure compliance.

Ensure required documentation is completed prior to product transfers and product launches.

Provide guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.

Facilitate risk management and change control activities.

Support processes such as document control, training, CAPAs, and developing quality metrics.

Identify opportunities for continual improvement and works with management and team members to successfully address these opportunities.

Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company's QMS.

Perform and document internal audits and make recommendations for corrective actions.

Perform other related duties and responsibilities as assigned.

Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.

Requirements :
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.

5+ years of quality experience in an FDA/ISO regulated environment.

Experience in molecular biology products or molecular diagnostic products.

Knowledge of applying statistical analysis for testing, process control, and design of experiments.


Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments.

Ability to work effectively in a team environment and build strong working relationships.

Ability to successfully balance and prioritize multiple ongoing projects and tasks in a fast-paced, deadline driven environment.

Excellent problem-solving and analytical skills.

Effective communication and interpersonal skills.

ASQ CQE certification is preferred.

May be required to lift routine office supplies and use office equipment.


The majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.

Ability to sit for extended periods of time.
  • Electrical Engineer

    Found in: beBee jobs US - 2 weeks ago


    Simi Valley, California, United States Entegee Full time

    Help architect and deliver components related to high performance antenna systems.Assures product quality by designing electric testing methods, testing finishing products and system capabilities.On-site installation, calibration, troubleshooting at the system level.5+ years of experience in electrical and communication system design in consumer/aerospace...

  • CNC ID Grinder

    Found in: beBee jobs US - 2 weeks ago


    Simi Valley, California, United States Regal Rexnord Corp Full time

    Rexnord Aerospace is a growing and profitable supplier of engineered high performance bearings and mechanical seals to the commercial air transport, regional aircraft, business aircraft, helicopter and military aircraft markets for use in engine systems, flight control systems, airframe structures and landing gear systems.Perform and maintain accurate...


  • Fountain Valley, United States CareerBuilder Full time

    Sr. Aerospace Manufacturing Engineer (79387-1) Duties and Responsibilities: Generate creative solutions to design problems and demonstrate their viability considering factors such as risk, reliability, manufacturability, serviceability, weight and cost. Transition concepts into products, defining requirements, selecting materials and processes, interacting...


  • West Valley City, United States Harris Geospatial Solutions Full time

    Job Title : Sr. Specialist, Systems EngineerJob Code: 8733Job Location : Salt Lake City-UTJob Schedule: 9/80, every other Friday offL3Harris Communication Systems segment is currently seeking a Lead, Systems Engineer to join our team. This position will be based at our Salt Lake City, UT facility.Position Overview:The Systems Engineer will be responsible for...

  • Quality Engineer

    1 week ago


    Huntingdon Valley, United States ALIGN PRECISION - PHILADELPHIA, LLC Full time

    Job DescriptionJob DescriptionJob Opening: Supply Quality EngineerWe are looking for a focused and meticulous supplier quality engineer. The responsibilities of the supplier quality engineer include reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues.To be successful as a supplier quality...

  • Quality Engineer

    4 days ago


    Huntingdon Valley, United States ALIGN PRECISION - PHILADELPHIA, LLC Full time

    Job DescriptionJob DescriptionJob Opening: Supply Quality EngineerWe are looking for a focused and meticulous supplier quality engineer. The responsibilities of the supplier quality engineer include reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues.To be successful as a supplier quality...

  • Quality Engineer

    6 hours ago


    Huntingdon Valley, United States ALIGN PRECISION - PHILADELPHIA, LLC Full time

    Job DescriptionJob DescriptionJob Opening: Supply Quality EngineerWe are looking for a focused and meticulous supplier quality engineer. The responsibilities of the supplier quality engineer include reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues.To be successful as a supplier quality...

  • Quality Engineer

    Found in: Appcast US C2 - 2 weeks ago


    Spokane Valley, United States Volex Full time

    We are seeking a highly skilled and detail-oriented Quality Engineer (QE) to play a pivotal role in ensuring the highest standards of Quality Control, Assurance, and reliability across their products and processes. The ideal candidate will have a strong understanding of Statistical Process Control (SPC), experience working in an ISO9001, ISO13485, and/or...

  • Quality Engineer

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago


    Spokane Valley, United States Volex Full time

    We are seeking a highly skilled and detail-oriented Quality Engineer (QE) to play a pivotal role in ensuring the highest standards of Quality Control, Assurance, and reliability across their products and processes. The ideal candidate will have a strong understanding of Statistical Process Control (SPC), experience working in an ISO9001, ISO13485, and/or...

  • Quality Engineer

    2 weeks ago


    Spokane Valley, United States Volex Full time

    We are seeking a highly skilled and detail-oriented Quality Engineer (QE) to play a pivotal role in ensuring the highest standards of Quality Control, Assurance, and reliability across their products and processes. The ideal candidate will have a strong understanding of Statistical Process Control (SPC), experience working in an ISO9001, ISO13485, and/or...

  • Quality Engineer

    2 weeks ago


    Valley City, United States Productive Resources LLC Full time

    Job DescriptionJob DescriptionQuality Engineer Valley City, ND - Full Time Productive Resources (www.productiveresources.com) is seeking a candidate to be part of our engineering team at the John Deere facility in Valley City, ND. As a member of our team, the selected candidate will provide quality planning, control, and improvement support for product...

  • Quality Engineer

    1 day ago


    Valley City, United States Productive Resources LLC Full time

    Job DescriptionJob DescriptionQuality Engineer Valley City, ND - Full Time Productive Resources (www.productiveresources.com) is seeking a candidate to be part of our engineering team at the John Deere facility in Valley City, ND. As a member of our team, the selected candidate will provide quality planning, control, and improvement support for product...

  • US - Sr Buyer.

    1 week ago


    Golden Valley, United States Aversan Full time

    Sr Buyer Aversan Inc. (www.aversan.com)is a reputable Engineering Company that provides expertise in Systems Integration and Software Testing for industries including Digital Health, Medical Devices, IT and Aerospace. We are currently seeking a qualified Sr Buyer to work on leading edge technology products. The successful candidate for this full-time...

  • Quality Engineer II

    1 week ago


    Valley City, United States Productive Resources LLC Full time

    Job DescriptionJob DescriptionQuality Engineer IIValley City, North Dakota - Full Time Productive Resources (www.productiveresources.com) is seeking a candidate to be part of our engineering team at John Deere's facility in Valley City, ND. As a member of our team, the selected candidate will provide quality planning, control, and improvement support for...


  • Valley City, United States Productive Resources LLC Full time

    Job DescriptionJob DescriptionQuality Engineer IIValley City, North Dakota - Full Time Productive Resources (www.productiveresources.com) is seeking a candidate to be part of our engineering team at John Deere's facility in Valley City, ND. As a member of our team, the selected candidate will provide quality planning, control, and improvement support for...


  • Fountain Valley, United States Hyundai Autoever America Full time

    Job DescriptionJob Description10457 - Sr. Business Process Analyst   Purpose:    The Sr. BPA (Business Process Analyst) is responsible for creating detailed requirements specifications for Connected Car development including new features and enhancements such as core platform and customer channels like web portal and mobile app. This includes...


  • Simi Valley, United States AphroSoft TechnoLogies Full time

    **Description - Quality Engineering Technician** **Job Designation** The Quality Engineering Technician provides expertise in setting-up and conducting product inspections, product evaluation, creating/updating quality process documentation, and operations support. **Job Core Responsibilities** ? Interpret drawings, procedures and process documents to...

  • Quality Engineer

    1 week ago


    West Valley City, United States Hammon Plating Corp Full time

    Quality Engineer Family owned Hammon Plating has been in business since 1969. As a leader and critical supplier in the cleaning and plating industry, we have set the standard with premium processes and procedures to support semi-conductor, biotech, solar and a variety of other industries. Currently, we are looking to expand and grow our organization by...


  • Simi Valley, United States EMLINQ LLC Full time

    Job DescriptionJob Description We are seeking a Quality Engineering Manager to join our team! Responsibilities: Responsible in managing the Quality Management System program in accordance with AS9100D, ISO 9001:2015, ISO 14001 and FDA 21 CFR 820 requirements Manage Internal Audit Schedule Program Supervise QC personnel and Quality Engineer Support inspection...


  • West Valley City, United States Knewin Full time

    Job Title: Sr. Specialist, Configuration ManagementJob Location: USA-UT-Salt Lake CityJob Code: 10544Job Schedule: 9/80, every other Friday offManages the setup of new programs including the creation of Configuration Management plans, and baselines. Implements and maintains an Engineering Change Request System. Changes will include product improvements,...


  • West Valley City, United States Laborie Medical Technologies Corp Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...

  • SR RESEARCH SCIENTIST

    Found in: Careerbuilder One Red US C2 - 13 hours ago


    Valley View, OH 44125, USA, United States Peak Nano Full time

    Sr Research ScientistJob Number: 1000009Job Type: Full Time, SalaryLocation: Valley View, OH - OnsiteAbout Peak NanoPeak is a US-based, AI-driven technology company that uses nanotechnology to solve macro-level global challenges. Our engineers and researchers are developing solutions for advanced optics, aerospace, life sciences, and other industrial...