Senior Quality Engineer

50 minutes ago

San Diego, California, United States Surf Search Full time

Join our cardiovascular EP client's rapidly growing team and help as they embark on an exciting phase of their development The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and/or sustaining manufacturing/operation teams. This role ensures products are developed per regulatory requirements, customer expectations, and industry standards.

Requirements of the Senior Quality Engineer:

  • Bachelor's degree in Engineering or scientific field with 3+ years of Quality Engineering, Manufacturing, or R&D experience
  • Medical Device experience required
  • Hands-on experience with Design Assurance, Design Controls, Design Verification & Validation, and Test Method Development
  • Experience working in the medical device industry
  • Strong working knowledge of risk management and hazard analysis (ISO 14971)
  • Familiarity with IEC 62304 and IEC highly preferred)
  • Strong technical writing skills with ability to create protocols, reports, and procedures

Responsibilities of the Senior Quality Engineer:

  • Provide Quality Engineering support across design controls, risk management (ISO 14971), and statistical techniques for medical device products
  • Lead design assurance activities including feasibility testing, verification & validation, process validation, and design transfer
  • Develop, review, and maintain QMS documentation including SOPs, work instructions, risk files, DHF, DMR, labeling, and change control
  • Manage CAPA, nonconformance investigations, supplier qualification, component qualification, and environmental monitoring activities
  • Support manufacturing operations through yield improvement, cost reduction initiatives, equipment qualification, and site transfers
  • Support internal and external audits, regulatory inspections, and corrective action resolution
  • Provide day-to-day quality support and training to cross-functional teams
  • Track and report key quality metrics aligned with business and compliance objectives

Occupational Category: Validation Engineers

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