Quality Engineer

1 week ago

Carlsbad, 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. Additionally, the role will maintain the Quality Management System (QMS) infrastructure, ensuring it is compliant, making changes to the system as needed to maintain ease of use.

Qualifications of the Quality Engineer:

  • A Bachelor’s degree in engineering or a related technical discipline, with a preference for mechanical, electrical, or chemical engineering.
  • 4+ years of experience in quality engineering, especially in new product development.
  • Quality experience with cardiovascular products and devices containing software - experience working with catheter devices is required.
  • Experience with electromechanical devices, including 60601 testing requirements.
  • Experience in validations (IQ, OQ, and PQ).
  • Strong knowledge of Design Controls, Risk Management, and manufacturing process controls.
  • Experience with FDA 21 CFR 820 and ISO Standards (ISO 13485 and ISO 14971).
  • Proficiency in statistical methods, process design tools, and reading engineering blueprints (CMM, GD&T).
  • Experience conducting risk analysis activities such as dFMEA, uFMEA, pFMEA, and hazard analysis.
  • Strong technical writing skills for protocols, reports, and manufacturing procedures.
  • ASQ Certified Quality Engineer (CQE) is preferred.
  • Experience with FDA 21 CFR 210 & 211 is a plus.
Responsibilities of the Quality Engineer:
  • Responsible for Design Quality Assurance for Catheters and Devices containing software.
  • Manage QMS functions related to management review, design control, risk management, CAPA, complaint handling, non-conformance, quality planning, document management, and change control.
  • Lead post-market quality activities, including vigilance reporting/MDRs.
  • Oversee complaint and CAPA systems, ensuring timely, accurate, and compliant documentation and reporting of MDRs or other actions.
  • Review and approve master batch records and resolve quality issues.
  • Maintain verification and monitoring programs to ensure QMS compliance with regulations and standards.
  • Act as the Management Representative, ensuring compliance with regulatory requirements, international standards, and company policies.
  • Direct Quality Assurance functions and lead inspections, audits, and compliance activities, maintaining relationships with regulatory bodies.
  • Lead Supplier Quality initiatives and manage internal and external audit resolutions.
  • Provide training on regulatory compliance, QMS, and related subjects.
  • Support quality initiatives to improve the overall quality of released products.
  • Perform and delegate responsibilities within QA to ensure timely achievement of company objectives.
  • Adhere to all policies, procedures, and business ethics codes.
Occupational Category: 17-2199.02 Validation Engineers

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