Senior Quality Engineer

3 weeks ago


Irvine, United States Hydrogen Group Full time

Summary:

A leading Medical Device company are actively seeking a motivated candidate to fill their Sr Quality Engineer opportunity. This is a 6-month contract, hybrid flexibility is based in Irvine, CA. Salary ranges between $54-59/hour depending on experience.

Requirements:

  • Bachelors Degree in Engineering plus 4 years Medical Device industry experience required.
  • Must have CAPA and Root Cause Analysis Investigation experience.
  • Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  • Hands on engineering experience with electronics preferred.

Key Responsibilities:

  • Manage all phases of the CAPA process for specific events, including documentation, RCA investigation, record management, and assembly of robust CAPA files in the CAPA Management System.
  • Quality Systems Engineering support, including Post-Market Quality Engineering support.
  • Train, coach, and guide employees on CAPA procedures.
  • Guide others in resolving basic issues in specialized area based on existing solutions and procedures.


  • Irvine, United States TalentBurst Full time

    Position: Senior Quality Engineer, Req#: 6228-1 Location: Irvine, CA  (100% onsite) Duration: 18 Months Contract   Job Description:  We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement,...


  • Irvine, United States TalentBurst Full time

    Position: Senior Quality Engineer, Req#: 6228-1 Location: Irvine, CA (100% onsite) Duration: 18 Months Contract Job Description: We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and...


  • Irvine, United States Planet Pharma Full time

    6 Month Contract (May extend or convert to perm)$58/hour W2Summary:The main function of a Senior Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.Key Responsibilities:Manage end to end CAPA process with the support of SMEs from a cross functional team. Work with the...


  • Irvine, United States Planet Pharma Full time

    6 Month Contract (May extend or convert to perm)$58/hour W2Summary:The main function of a Senior Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.Key Responsibilities:Manage end to end CAPA process with the support of SMEs from a cross functional team. Work with the...


  • Irvine, United States Cynet Systems Inc. Full time

    Skills : Professional level proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint, MS Project). Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge). Knowledge of Six Sigma concepts with the ability to apply to work product. Working...


  • Irvine, United States Edwards Lifesciences Full time

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because were committed to creating a world whe Engineer, Quality, Senior, Technology, Manufacturing


  • Irvine, United States Edwards Lifesciences Full time

    For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because were committed to creating a world where every patient who sho Engineer, Quality, Senior, Technology, Experience


  • Irvine, United States Cynet Systems Full time

    Job Description: Pay Range $54.18hr - $59.18hr Responsibilities: Manage end-to-end CAPA process with the support of SMEs from a cross-functional team. Work with the CAPA owners and lead investigations of complex manufacturing product quality and compliance issues (e.g., CAPA, audit observations) for all production processes based on engineering...


  • Irvine, United States Compunnel Inc. Full time

    Summary:The main function of a Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.Key Responsibilities:Manage end to end CAPA process with the support of SMEs from a cross functional team. Work with the CAPA owners and lead investigations of complex manufacturing...


  • Irvine, United States Compunnel Inc. Full time

    Summary:The main function of a Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.Key Responsibilities:Manage end to end CAPA process with the support of SMEs from a cross functional team. Work with the CAPA owners and lead investigations of complex manufacturing...


  • Irvine, United States Planet Pharma Full time

    (This is a 6-month contract, with potential to convert/extend, available to candidates local to the Irvine, CA area)Summary:The main function of a Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.Key Responsibilities:Manage end to end CAPA process with the support of...


  • Irvine, United States ShiftCode Analytics Full time

    Title: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: •Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process...


  • Irvine, United States Edwards Lifesciences Full time

    Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...


  • Irvine, United States Edwards Lifesciences Full time

    Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...

  • Quality Engineer

    1 month ago


    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Senior Quality Engineer, Req#: 6228-1Location: Irvine, CA (100% onsite)Duration: 18 Months Contract Job Description:We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and...

  • Quality Engineer

    1 month ago


    Irvine, United States TalentBurst Full time

    Position: Senior Quality Engineer, Req#: 6228-1 Location: Irvine, CA (100% onsite) Duration: 18 Months Contract Job Description: We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and...

  • Quality Engineer

    1 month ago


    Irvine, United States TalentBurst, an Inc 5000 company Full time

    Position: Senior Quality Engineer, Req#: 6228-1Location: Irvine, CA (100% onsite)Duration: 18 Months Contract Job Description:We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and...


  • Irvine, United States Quality Analytics Inc Defunct Full time

    Engineering, Technical, or Scientific discipline with minimum of 5-8 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated). Good Experience in IQ / OQ / PQ processes at Mfg sites Quality Engineering/Design or Process Excellence/Lean experience is preferred. Collaborate to complete Component Qualification,...


  • Irvine, United States JobRialto Full time

    Job Description: Summary: The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret drawings. Job Responsibilities: Applies knowledge of...


  • Irvine, United States Compunnel Inc. Full time

    Title: Sr Quality EngineerPay: 57-62 USD/HR on W2Location: Irvine, CADuration: 6 MonthsJob Description:Summary:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis...