Sr. Manufacturing Quality Engineer

4 weeks ago

Irvine, United States Infosoft, Inc. Full time

Job Title: Sr. Manufacturing Quality Engineer (Electrical/Electronics Products)

Pay Rate: $60 to $65.67/HR

Duration: 6 Months

Location: Irvine, CA (Hybrid - 2 to 3 Days onsite in a week)


Our Client is a Global medical device Manufacturer.


We are looking for Sr. Manufacturing Quality Engineer. 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. We are looking for candidates with CAPA and Root Cause Analysis investigation experience.


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 product quality and compliance issues (e.g., CAPA, audit observations) for all production processes based on engineering principles.
  • Perform robust root cause analysis investigation, develop, and implement corrective actions, and establish effectiveness monitoring plans.
  • Manage all phases of the CAPA process for specific events, including documentation, root cause analysis investigation, record management, and assembly of robust CAPA files within the CAPA Management System.
  • Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Client's systems/procedures.
  • Quality Systems Engineering support, including Post-Market Quality Engineering support.
  • Guide others in resolving basic issues in specialized areas based on existing solutions and procedures.
  • Train, coach, and guide employees on CAPA procedures.
  • Other incidental duties assigned by Leadership.


Education and Experience:

  • Bachelor’s Degree in Engineering or related field plus 4 years relative regulated industry experience required; Electrical Engineering degree preferred.
  • A Master’s Degree will offset one (1) year of required 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 is preferred
  • ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred.


Additional 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 them to work product.
  • Working knowledge and understanding of statistical techniques.
  • Ability to read and interpret drawings.
  • Strong leadership skills and ability to influence change.
  • Ability to prioritize, plan & evaluate deliverables to establish strategic goals.
  • Proficient knowledge of Quality Engineering concepts relative to the level of role (Senior Engineer)
  • Experience with automation, software testing, and software validation is strongly preferred.
  • Must be able to work in a collaborative team environment, including inter-departmental teams and key contacts for internal and outside customers.
  • May work on resolution of complex technical issues or projects where precedent may not exist
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.

  • Sr Manufacturing Engineer

    2 months ago

    Irvine, United States Turion Space Full time

    Job DescriptionJob DescriptionDescriptionTurion Space is seeking a Sr Manufacturing Engineer to join our team in Irvine, CA. The Manufacturing Team is responsible for rapidly iterating and building cutting-edge hardware, including static equipment, moving ground equipment, and flight vehicles. This responsibility includes everything in the manufacturing...

  • Supplier Quality Engineer

    3 weeks ago

    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,...

  • Senior Quality Engineer

    1 week ago

    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...

  • Senior Quality Engineer

    2 weeks ago

    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...

  • Sr Engineer

    4 weeks ago

    Irvine, United States Ledgent Technology Full time

    Roth Staffing is looking for a Sr Engineer (CAPA) within the medical technologies firm.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...

  • Sr Engineer

    4 weeks ago

    Irvine, United States Ledgent Technology Full time

    Roth Staffing is looking for a Sr Engineer (CAPA) within the medical technologies firm. 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...

  • Sr Engineer

    3 weeks ago

    Irvine, United States Ledgent Technology Full time

    Roth Staffing is looking for a Sr Engineer (CAPA) within the medical technologies firm.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...

  • Sr Engineer

    3 weeks ago

    Irvine, United States Ledgent Technology Full time

    Roth Staffing is looking for a Sr Engineer (CAPA) within the medical technologies firm.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...

  • Manufacturing Engineer

    2 months ago

    Irvine, United States People With Chemistry Full time

    Senior Manufacturing Engineer (Onsite) A growing electrosurgical medical device company located in Orange County is looking to hire a Senior Engineer for their manufacturing engineering department. The company is developing electromechanical devices for Orthopedic, Neuro, Spine, and Dental Surgery. This role will lead and execute manufacturing projects to...

  • Manufacturing Engineer

    3 days ago

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

    Position: Manufacturing Engineer II, Req#: 7659-1Location: Irvine, CA (100% onsite)Duration: 6+ Months Contract Shift: M-F, 12:00 PM – 8:30 PM, possibility of overtimeJob Description:The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical...

  • Sr Quality Engineer

    4 weeks ago

    Irvine, United States MKS Instruments Full time

    The Sr.Quality Coatings Engineer will be responsible for providing high level technical support for Newport Optics (NPO) QC Inspection area. Performs and trains others in QC test and inspection processes and makes decisions on product and process acceptability. Recommends appropriate test and measurement equipment and arranges for equipment calibration....

  • Sr. Supplier Quality Engineer

    2 months ago

    Irvine, United States Endologix Full time

    Overview: Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company...

  • Sr Quality Engineer

    2 months ago

    Irvine, United States MKS Instruments Full time

    The Sr.Quality Coatings Engineer will be responsible for providing high level technical support for Newport Optics (NPO) QC Inspection area. Performs and trains others in QC test and inspection processes and makes decisions on product and process acceptability. Recommends appropriate test and measurement equipment and arranges for equipment calibration....

  • Sr Engineer, Mechanical

    4 weeks ago

    Irvine, United States Masimo Full time

    Job DescriptionJob Summary: The Sr Mechanical Engineer- Capnography is responsible for the new mechanical design, development, validation, and sustaining of the company's patient monitoring devices and instruments. Will utilize engineering knowledge and experience to solve problems and elevate Masimo's product design, quality, and innovation. Duties &...

  • Sr Engineer, Mechanical

    1 month ago

    Irvine, United States Masimo Full time

    Job DescriptionJob Summary: The Sr Mechanical Engineer- Capnography is responsible for the new mechanical design, development, validation, and sustaining of the company's patient monitoring devices and instruments. Will utilize engineering knowledge and experience to solve problems and elevate Masimo's product design, quality, and innovation. Duties &...

  • Manufacturing Engineer

    1 month ago

    Irvine, United States ITT Full time

    Position Summary: ITT is a leading $2.5B global manufacturer of highly engineered, customized solutions with approximately 8000 employees operating in 35 countries around the globe. The Irvine site operation is a low volume, high mix manufacturing and final assembly facility specialized on reliable rugged connectors for the Aerospace & Defense industry. ITT...

  • Manufacturing Engineer

    7 days ago

    Irvine, United States Trinus Corporation Full time

    We seek a Manufacturing Engineer for a leading global medical technology company specializing in advancements in heart valve therapies and critical care monitoring. Established in 1958 and based in Irvine, California, the company excels in developing products and technologies aimed at treating structural heart disease and patients in critical condition. ...

  • Manufacturing Engineer

    2 months ago

    Irvine, United States EVONA Full time

    Senior Manufacturing Engineer | Space Start Up | Irvine Want to work for an exciting start up business in the space industry? This is an exciting opportunity to be the first manufacturing hire, into an exciting new space company. Responsibilities: Build out manufacturing processes Take new products from conceptual design to the production line Develop...

  • Manufacturing Engineer

    1 week ago

    Irvine, United States Trinus Corporation Full time

    We seek a Manufacturing Engineer for a leading global medical technology company specializing in advancements in heart valve therapies and critical care monitoring. Established in 1958 and based in Irvine, California, the company excels in developing products and technologies aimed at treating structural heart disease and patients in critical...

  • Manufacturing Engineer

    2 weeks ago

    Irvine, United States Grove Technical Resources, INC Full time

    Job Title - Manufacturing EngineerJob Location - Irvine, California (Fully Onsite)Type: W2 contract Required Skills:1. Process Validation experience for medical devices 2. Cycle time, Yield and Process Flow improvement experience 3. Documentation – BOM, Work Instructions, visual aids, MP, change order documentation. Education Required: Mechanical,...