Senior Quality Engineer

Company : TalentBurst, Inc.

Country: United States

Location : Irvine, California

Post: Thu, 12 Jan 2023 20:50:16 GMT

Expires: Sat, 11 Feb 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position: Senior Quality Engineer, Req#: 428-1
Location: Irvine, CA (100% onsite)
Duration: 6+ Months Contract

Job Description:

Education and Experience:

* Bachelor’s degree in Engineering or Scientific field with a minimum of 4 years relevant experience in Quality Engineering, Quality Operations, Quality Systems, or Manufacturing; OR Masters degree in Engineering or Scientific field with 3 years of experience.

Skills:

* GDP and GMP proficiency and experience working in a medical device, pharma, or biotech industry
* Understanding of manufacturing, quality, and risk management standards
* Communication and presentation skills for cross-functional & cross-level collaboration
* Experience working with inspection and measurement tools & equipment (e.g., microscope, TAPPI, burst tester, tensile tester)
* Nonconformance and CAPA management experience utilizing investigation tools for root cause analysis (e.g., Five Whys Analysis, Fishbone diagram, Flow Chart/Process Mapping)
* Technical writing skills NCR, Manufacturing & Inspection SOP, Technical Reports, Validations
* Working knowledge of statistical data analysis and SPC (Minitab proficiency)
* Knowledge of Risk Management processes and tools
* Process / Equipment qualification & validation experience (Test method validation, IQ/OQ/PQ, Tool and fixture IQ)
* Ability to manage competing priorities in a fast-paced environment
* Expertise in the usage of MS Office Suite

Key Responsibilities:

* Investigate manufacturing product quality and compliance issues reported internally and/or from the field, analyze results, determine root causes, and initiate and review reports (e.g., Non-Conformances, CAPA, Audit resolutions)
* Assess reported events against established procedures and risk control documentation for clinical and compliance risk(s) and escalate to Quality Management as needed
* Initiate and manage Enterprise Change Request (ECR) to implement procedure changes
* Lead technical studies and author technical reports. Implement statistical techniques to determine sample sizes and levels of confidence
* Review engineering documents to ensure quality and compliance
* Provide guidance and leadership as needed on key team projects/activities to help achieve team PMOs and Quality Objectives.
* Other incidental duties assigned by Leadership