Jobs
>
Rutherford

    Supplier Quality Engineer - Rutherford, United States - Ortho Clinical Diagnostics

    Ortho Clinical Diagnostics
    Ortho Clinical Diagnostics Rutherford, United States

    2 weeks ago

    Default job background
    Description


    The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.

    We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

    Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement.

    We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.

    Join us in our mission to transform the power of diagnostics into a healthier future for all.
    The RoleAs we continue to grow as QuidelOrtho, we are seeking a Supplier Quality Engineer. The Supplier Quality Engineer interacts with the Company's suppliers on matters related to product quality.

    This position maintains and improves the Company's Supplier Management System which includes supplier qualifications, supplier audits, supplier corrective action process and scorecards.

    Leads complex root cause failure investigations and troubleshooting of customer complaints and product nonconformances within manufacturing. This position will also support incoming inspection in a technical capacity related to inspections. Acts as the champion of Quality System compliance.
    This position will be onsite working at our Carlsbad, CA office. There will be 15-20% domestic travel required.
    The ResponsibilitiesEvaluates suppliers for technical capability and quality system performance. Leads and positively influences product improvements of supplied products through effective use of the Company's quality system.

    Leads the site effort in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition of material.

    Resulting in sound corrective action at the supplier site to prevent reoccurrence.

    (SCAR System Administration).Actively reviews existing Raw Material Specifications, supplier capability, and the corresponding Receiving Inspection Instructions for accuracy and applicability.

    Supports (including leading as needed) root cause failure investigation activities.
    Writes/edits/approves investigation reports.
    Participates in Complaint Committee meetings and present investigation findings to peers and management.

    Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and improvement actions.

    Performs statistical analysis of data from experiments and manufacturing process trend monitoring.
    Attends and actively participates in Management Review Board and presents findings and recommendations.
    Perform other work-related duties as assigned.


    The IndividualRequired:
    B.S.

    in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.3-5 years' experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments.

    Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments / Sampling Plans.

    Experiences in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Ishikawa, Kepner / Tregoe etc.

    Strong technical aptitude and experience is a required, level of technical writing skills and abilities.


    Excellent communication:
    ability to communicate effectively with all levels of employees throughout the organization.
    Able to develop and maintain strong working relationships with internal and external customers.
    Must have a strong understanding of manufacturing and quality systems principles is required.


    Preferred:
    Minimum 3 years' experience in Supplier Quality Engineering. Supplier Quality skills and experience including auditing, performance management and SCAR management.
    Experience working with injection molding.
    Experience interacting with Regulatory Bodies (FDA, ISO). Medical Device Manufacturing experience.
    Knowledge of quality systems and regulations for medical device industry.
    Ability to lead and facilitate a group of technical experts (including suppliers) in root cause investigations. Proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
    Advance skills in statistical techniques and methods required.
    ASQ Quality Engineer Certification (CQE).


    The Key Working RelationshipsInternal Partners:


    With all levels of Manufacturing, on a regular basis on such activities as implementing daily inspection activity, conducting product and system failure analysis, supporting the non-conforming material system, releasing product, reviewing/closing documentation, implementing corrective and preventive action, performing systems assessment/feedback and supporting product/process validations.

    Works closely with Quality Assurance in complaint analysis and provides input to risk-based decisions.
    Works closely with individual buyers will actively manage the supply base through data, analysis, metrics and business reviews.

    Interacts with all levels in providing technical guidance and support for supplier management, material control and compliance issues, resolving non-conforming materials, and supporting departmental/corporate goals and objectives and process improvements.

    Support as needed supplier nonconformances that result in complaints or other regulatory considerations.

    Collaborates with the engineering staff and management on conducting technical failure analysis to resolve and preclude quality issues, supporting supplier process validations, and supporting departmental/corporate goals and process improvements.


    External Partners:
    Vendors and customers.
    The Work EnvironmentThe work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of manufacturing goals.
    Position requires ability to travel up to 25-30% of the time. Position requires ability to lift up to 20 lbs. on occasion.

    Up to 50% at desk, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role.

    Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

    Salary TransparencyThe salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data.

    At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case.

    The salary range for this position is $92,000 to $156,000.

    QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

    All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

    Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.

    QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at

  • Stellar Enterprises

    Quality Engineer

    2 weeks ago


    Stellar Enterprises San Lucas, United States

    At San Lucas, we specialize in producing high-quality acoustic solutions for renowned automotive manufacturers. We are currently seeking individuals who are eager to grow and develop with us. We are looking for a QUALITY ENGINEER (M/W/D) to join our team in quality assurance at o ...

  • Vestas

    Quality Engineer

    2 weeks ago


    Vestas Windsor, United States

    | · Full-Time · | · Quality, Health, Safety and Environment · Job Title: Quality Engineer · Location(s); Windsor, CO · Salary: $80 -105k based on relevant experience. · Job Description: · Responsibilities: · Lead, define, and implement quality KPIs strategic, coaching, and busi ...

  • Kodak Alaris

    Quality Engineer

    2 weeks ago


    Kodak Alaris Windsor, United States

    Kodak Alaris · is a global technology company that's delivering future value through customer solutions. Our advanced, patented intellectual property combines breakthrough technologies, digital transformation, and human know-how to unlock the power of images and information. We ...

  • Longwood University

    Quality Engineer

    2 weeks ago


    Longwood University Petaluma, United States

    You are viewing a preview of this job. Log in · or register · to view more details about this job. · Join a diverse team that supports the mission of the US Navy Naval Nuclear Laboratory (NNL) Naval Reactors Facility (NRF) Quality Engineering and Assessment (QE&A) provides dire ...

  • Kelly Services, Inc.

    Sr Quality Engineer

    4 weeks ago


    Kelly Services, Inc. Santa Rosa, United States

    Kelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Senior Quality Engineer for a long-term engagement at one of our Global Medical Device Manufacturing clients lo Quality Engineer, Quality, En ...


  • Raytheon Technologies Corporation Fairfield, United States

    Manages Quality Engineering operational plans and initiatives with a direct impact on reducing non-conformities and ensuring quality standards are in effect. Manages implementation of solutions to nonconformities and to satisfy quality issues raised Quality Engineer, Engineering ...


  • Viavi Solutions Santa Rosa, United States

    Summary: Duties & Responsibilities: Position Overview:As a Supplier Quality Engineer, you will be responsible for evaluating, monitoring, and improving the quality performance of our suppliers. You will work closely with our procurement, engineering, and manufacturing teams to dr ...


  • Viavi Solutions Santa Rosa, United States

    Summary: · Duties & Responsibilities: · Position Overview: · As a Supplier Quality Engineer, you will be responsible for evaluating, monitoring, and improving the quality performance of our suppliers. You will work closely with our procurement, engineering, and manufacturing ...


  • Kelly Science, Engineering, Technology & Telecom Santa Rosa, United States

    Kelly Science, Engineering, Technology and Telecom · a managed solution provider and business unit of Kelly Services, is currently seeking a · Senior Quality Engineer · for a long-term engagement at one of our · Global Medical Device Manufacturing · clients located in · San ...


  • Katalyst HealthCares & Life Sciences Santa Rosa, United States

    Role and Responsibilities: Collaborate with cross-functional teams to establish quality and performance metrics for suppliers. · Establish regular connects with supplier to evaluate Material changes to Parts/Components and decide the implementation actions. · Monitor and track ...


  • Vestas Windsor, United States

    Job Title: Quality Engineer · Location(s); Windsor, CO · Job Description: · Responsibilities: · • Lead, define, and implement quality KPIs strategic, coaching, and business support. · • Proactively identifies and develops and implements appropriate approaches, processes and tool ...


  • Endologix Santa Rosa, United States

    Overview: · Facilitate compliance to applicable internal and external requirements for the Design Control process. Collaborate with R&D, Regulatory, Clinical, Manufacturing, and other departments to help facilitate the successful execution of the Design Control and Risk Manageme ...


  • EnPro Santa Rosa, United States

    POSITION SUMMARYResponsible for all aspects of the Quality Management System (QMS), including but not limited to identifying and implementing improvements and maintenance of the system to ensure compliance with ISO and customer quality requirements. · All duties require a commitm ...


  • Endologix Santa Rosa, United States

    Overview · Facilitate compliance to applicable internal and external requirements for the Design Control process. Collaborate with R&D, Regulatory, Clinical, Manufacturing, and other departments to help facilitate the successful execution of the Design Control and Risk Managemen ...


  • EnPro Santa Rosa, United States

    Assistant Professor - Bioethics (Tenure Track) · Job no: · 496035 · Full time/Part time: · Full-time · Location: · South Orange · Categories: · Faculty · Seton Hall University is hiring a tenure-track Assistant Professor in Philosophy to begin in the Fall 2024. AOS in Bioet ...

  • Cascade Innovations

    Dual Study

    2 weeks ago


    Cascade Innovations Angwin, United States

    Dual Study Program – Bachelor of Engineering (B. Eng) – Mechanical Engineering with a focus on Production TechnologyWhen studying, one often misses the practical relevance. Those who are in an apprenticeship may wish for more theoretical instruction and specialization. At AbbVie, ...


  • beBee Handyman Fetters Hot Springs-Agua Caliente, CA, United States Freelance

    I am in need of a car cleaning service with the following characteristics in Fetters Hot Springs-Agua Caliente, CA:What type of vehicle is the cleaning service for? · Car · Type of cleaning requested for the vehicle · Interior · What should be included in the cleaning service? · ...


  • City of Santa Rosa, CA Santa Rosa, United States

    **The Position**: · **THE BENEFITS OF CITY EMPLOYMENT**: · **In addition to offering a rewarding work environment, opportunity for career growth, and excellent salary, the City of Santa Rosa provides a generous suite of benefits, including retirement through CalPERS, a competitiv ...

  • NV5

    Survey Technician

    3 weeks ago


    NV5 Santa Rosa, United States

    Overview: · NV5 (NASDAQ: NVEE) provides engineering and consulting services to public and private sectors, delivering solutions through five business verticals: Construction Quality Assurance, Infrastructure, Energy, Program Management, and Environmental. With offices nationwide ...


  • Sonoma Technology Petaluma, United States

    Selected by the _North Bay Business Journal_ as one of the Best Places to Work for the 17th consecutive year, Sonoma Technology is a consulting firm that provides innovative, science · - and technology-based solutions for our clients' environmental challenges worldwide. Our integ ...