Current jobs related to Quality Engineer - Irvine - Compunnel Inc.

  • Quality Engineer

    1 month ago

    Irvine, United States Compunnel Inc. Full time

    Title: Quality EngineerPay: 50-55 USD/HR on W2Duration: 12 MonthsLocation: Irvine, CA 92614Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production.A typical manufacturing engineer has the ability to make engineering drawings and read and interpret...

  • Quality Engineer

    1 month ago

    Irvine, United States Compunnel Inc. Full time

    Title: Quality EngineerPay: 50-55 USD/HR on W2Duration: 12 MonthsLocation: Irvine, CA 92614Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production.A typical manufacturing engineer has the ability to make engineering drawings and read and interpret...

  • Quality Engineer

    7 hours ago

    Irvine, United States Hydrogen Group Full time

    Quality Engineer Irvine, CA Schedule: Standard Office Hours Duration: 6-Month Contract Pay range: $35.00 - $40.00 Job Responsibilities: In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include: Leading multiple quality-related projects, including: Investigating customer...

  • Quality Engineer

    2 days ago

    Irvine, United States Hydrogen Group Full time

    Quality Engineer Irvine, CA Schedule: Standard Office Hours Duration: 6-Month Contract Pay range: $35.00 - $40.00 Job Responsibilities: In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include: Leading multiple quality-related projects, including: Investigating customer...

  • Quality Engineer

    6 days ago

    Irvine, United States Intellectt Inc Full time

    Role: Quality EngineerLocation: Irvine, CA - 92614Duration: 6 Months Job Description:Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.Execute complaint investigations multifunctional approach and issues...

  • Quality Engineer

    6 days ago

    Irvine, United States Intellectt Inc Full time

    Role: Quality EngineerLocation: Irvine, CA - 92614Duration: 6 Months Job Description:Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.Execute complaint investigations multifunctional approach and issues...

  • Quality Engineer

    3 weeks ago

    Irvine, United States Compunnel Inc. Full time

    Job Description:Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.Oversight of all complaints...

  • Quality Engineer

    3 weeks ago

    Irvine, United States Compunnel Inc. Full time

    Job Description:Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.Oversight of all complaints...

  • Quality Assurance Engineer

    2 weeks ago

    Irvine, California, United States Jobot Full time

    Quality Engineer OpportunityWe are seeking a highly skilled Quality Engineer to join our innovative team at Jobot. As a Quality Engineer, you will play a critical role in ensuring the quality and integrity of our medical devices.Key Responsibilities:Elevate product quality through continuous improvement techniques, including Six Sigma, Product and Process...

  • Head of Quality Engineering

    1 month ago

    Irvine, California, United States BioTalent Full time

    Position: Director of Quality Engineering - OrthoLocation: Irvine, CA (primarily on-site)Overview:BioTalent is in search of a highly qualified and seasoned Director of Quality Engineering to spearhead our Quality Engineering division. This role is crucial in maintaining the utmost quality standards for our medical device offerings, particularly in the spinal...

  • Director of Quality Engineering

    2 months ago

    Irvine, United States BioTalent Full time

    Job Title: Director of Quality Engineering - Ortho Location: Irvine, CA (primarily on-site)Job Summary:We are seeking a highly skilled and experienced Director of Quality Engineering to lead our Quality Engineering team in ensuring the highest standards of quality for our medical device products, with a focus on spinal and orthopedic devices. The ideal...

  • Director of Quality Engineering

    2 months ago

    Irvine, United States BioTalent Full time

    Job Title: Director of Quality Engineering - Ortho Location: Irvine, CA (primarily on-site)Job Summary:We are seeking a highly skilled and experienced Director of Quality Engineering to lead our Quality Engineering team in ensuring the highest standards of quality for our medical device products, with a focus on spinal and orthopedic devices. The ideal...

  • Service Quality Engineer

    2 weeks ago

    Irvine, California, United States Kia America Full time

    Service Quality EngineerAt Kia America, we're committed to delivering exceptional quality and customer satisfaction. As a Service Quality Engineer, you'll play a critical role in ensuring our vehicles meet the highest standards of performance, reliability, and safety.Key Responsibilities:Investigate and analyze product quality/service concerns related to Kia...

  • Senior Quality Engineer

    4 weeks ago

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

    Position: Sr. Quality Engineer, Req#: 7373-1Location: Irvine, CA (hybrid/flex position, 2-3 Days onsite in Irvine, CA) Duration: 6+ Months Contract Job Description: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.Education and Experience:...

  • Senior Quality Engineer

    4 weeks ago

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

    Position: Sr. Quality Engineer, Req#: 7373-1Location: Irvine, CA (hybrid/flex position, 2-3 Days onsite in Irvine, CA) Duration: 6+ Months Contract Job Description: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.Education and Experience:...

  • Service Quality Engineer

    4 days ago

    Irvine, California, United States Kia America Full time

    Job Title: Service Quality EngineerWe are seeking a highly skilled Service Quality Engineer to join our team at Kia America. As a key member of our Ownership Experience - Product Quality team, you will play a critical role in representing the voice of the North American customer in identifying vehicle quality concerns and developing countermeasures for our...

  • Quality Engineer

    2 weeks ago

    Irvine, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a Quality Engineer to lead the development and optimization of manufacturing processes, execute complex tests, and address quality and compliance issues within the medical device industry.Requirements:Bachelor's degree in engineering.5-7 years of experience in a related field.Proficiency with engineering...

  • Principal Quality Engineer

    2 weeks ago

    Irvine, California, United States Edwards Lifesciences Full time

    About the RoleWe are seeking a highly skilled Principal Quality Engineer to join our team at Edwards Lifesciences. As a key member of our Critical Care division, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesLead design assurance and development activities for New Product Development programs,...

  • Principal Quality Engineer

    1 week ago

    Irvine, California, United States Medtronic Full time

    About the RoleWe are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our Operations Quality OC Campus, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Key ResponsibilitiesDevelop and implement quality standards and protocols for processing materials into...

  • Principal Quality Engineer

    2 days ago

    Irvine, California, United States Medtronic Full time

    About the RoleWe are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a Principal Quality Engineer, you will be responsible for ensuring the quality of our products and processes, and for driving process improvements across the organization.Key ResponsibilitiesDevelop and implement quality standards and protocols for...

Quality Engineer

3 months ago

Irvine, United States Compunnel Inc. Full time

Job Description: 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 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 systems/procedures.

• Quality Systems Engineering support, including Post-Market Quality Engineering support.

• Guide others in resolving basic issues in specialized area 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.

• 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 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, Power Point, 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 ability to apply 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 established 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 contact 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 environment and prevention of pollution under their span of influence/control.