Compliance Specialist Job at Intellectt Inc, Lake Forest, CA

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  • Intellectt Inc
  • Lake Forest, CA

Job Description

Title: Compliance Engineer

Location: Lake Forest Drive, Lake Forest, CA

Submission Requirements: Driver's License and H1 Copy

NOTE:-

  • Kindly note, the role requires expert-level knowledge of IEC 60601-1 testing .
  • The client is open to H1B, U.S. Citizens, and Green Card holders.

Job Description:

The contractor will work onsite and must possess expertise in the IEC 60601-1 series of standards , including applicable test methods for medical devices. Experience with accredited safety agencies such as UL, TUV SUD, Intertek, CSA, etc., is preferred.

Role Requirements:

  1. Education & Experience:
  • BS in Electrical Engineering (or related field) + 4 years of experience in medical device product safety compliance or fully accredited test labs (e.g., UL, CSA, Intertek).
  1. Standards Expertise:
  • Expert knowledge of IEC 60601-1 (3rd Ed: 3.1, 3.2) standards, including collateral and particular standards for medical electrical equipment.
  1. Collaborative Skills:
  • Proven ability to work effectively with cross-functional teams.

Core Responsibilities:

  • Conduct safety certification test assessments throughout the development lifecycle.
  • Provide input to R&D teams for product development and risk mitigation.
  • Perform safety testing on Alcon products in both internal and external labs.
  • Prepare documentation for safety certification activities, including isolation diagrams, dielectric testing, and construction evaluations.
  • Coordinate with labs, technicians, and design engineers to achieve optimal testing outcomes.
  • Document and execute verification and validation tests compliant with medical device regulations (QSR, ISO 13485).
  • Prepare comprehensive test plans and reports with strong technical writing skills.
  • Plan and execute global safety certification testing of electrical equipment.
  • Maintain safety equipment and ensure calibration standards.
  • Familiarity with ISO 14971 Risk Management and IEC 60601-1-2 EMC testing procedures is highly desirable.

Job Tags

For contractors, H1b,

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