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Quality Engineer

4 months ago

Irvine, United States Compunnel Inc. Full time

Job Description: The main function of a Senior Post Market Quality Engineer is to perform engineering evaluation for customer complaints and support Post Market Surveillance activities.

Key Responsibilities:

• Manage Customer Complaints Engineering Evaluations during the course of complaint investigation and resolution process.

• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations.

• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered.

• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.

• Support Post Market Surveillance activities.

• Assist in projects and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint.

Additional Skills:

  • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related regulated industry required.
  • Proven expertise in MS Office Suite and ability to operate general office machinery.
  • Excellent written and verbal communication skills and interpersonal relationship skills.
  • Demonstrated problem-solving , critical thinking, and investigative skills.
  • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
  • Good knowledge of medical terms and human anatomy.
  • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations.
  • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
  • Ability to manage confidential information with discretion.
  • Experience with statistical software ( Minitab etc.).
  • Attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast paced environment.
  • Work is performed independently on complex work and reviewed for accuracy and soundness.

Education and Experience:

  • Bachelor's Degree in Engineering or related field.

5-7 years of experience required.