Senior Quality Engineer

Company: Real Staffing
Location: Carlsbad
Posted on: April 10, 2025

Job Description:

We have a current opportunity for a Senior Quality Engineer - Process on a permanent basis. The position will be based in Carlsbad. For further information about this position please apply.The position will be responsible for providing quality engineering support and leadership for Manufacturing Process development and implementation. This position will work closely with Manufacturing in the manufacture of disposable medical catheters in compliance with applicable regulatory and statutory requirements.Roles and Responsibilities:

• Review and approve manufacturing validation test plans, protocols, and test reports.
• Lead the completion of risk management deliverables, including process Failure Mode and Effects Analysis (pFMEA) and Control Plans.
• Support and lead test method validation activities to ensure accurate and reliable testing processes.
• Develop, review, and approve inspection plans, Device History Records (DHR), and product drawings for new products.
• Create and implement quality plans as needed to ensure product and process compliance.
• Develop activities aimed at preventing and detecting defects during the manufacturing process.
• Recommend and provide statistical support, expertise, and analytical problem-solving for process validations and Engineering Protocols.
• Support activities related to Management Reviews, internal and external audits, deviations, Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), Supplier Management, and Returned Goods Authorization (RGA).
• Provide support to the New Product Development team activities.
• Lead the resolution of quality issues related to NCRs and CAPAs.Must have:
  • 5+ Years of Experience in Medical Device Quality
  • Disposable Experience - Ideally Catheter
  • Hands-on process experience - ex. Writing and executing protocols, IQ/OQ/PQ, TMV
  • Experience Supporting Manufacturing lines
    #J-18808-Ljbffr

Keywords: Real Staffing, San Diego , Senior Quality Engineer, Engineering , Carlsbad, California