Senior Quality Engineer

7 days ago

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

Position: Sr. Quality Engineer, Req#: 7373-1

Location: 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:

  • 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).
  • Need somebody with CAPA and Root Cause Analysis investigation experience.
  • 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.


Other Details:

What does this group do? We manage CAPAs. (CAPAs, NCRs, Change Control, Training, Document Control, and Records Retention).

Does this team use any specific technology/software you want us to look out for? My team is using EQMS, Ignite, and JDE.

What will the work schedule be? Can any overtime be expected? From 8:00 AM to 5:00 PM. Yes, there are days that we probably will need to work more than 8 hours, it depends on the timeline of the CAPAs, projects, etc.

Will you consider remote work? If yes, will they need to be in a specific time zone? Yes, this is a hybrid/flex position, Pacific Coast time zone.

What are your top 3 required technical skills? Must haves? Engineering degree, CAPA experience, investigation experience, technical skills, team player, independent, quality experience.

What are nice to have skills? Project Management


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 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.


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.
  • 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.

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