Senior Quality Engineer

6 days ago


Fort Atkinson, Iowa, United States Ventura Solutions LLC Full time
About the Position

We are seeking a highly skilled Senior Quality Engineer to join our team at Ventura Solutions LLC in Union City, CA. As a Direct Placement employee, you will be responsible for providing technical support and ensuring compliance with quality and regulatory standards.

Estimated Salary: $120,000 - $180,000 per year

Job Description

The successful candidate will have a strong background in quality engineering and medical device development, with experience in design control processes, risk management, and validation protocols. You will work closely with cross-functional teams to ensure product compliance with regulations and industry standards.

Your Key Responsibilities Will Include:

  • Designing and executing validation protocols for manufacturing processes and product testing
  • Collaborating with the Design and Development Team to ensure product development meets quality and regulatory standards
  • Reviewing documentation, test results, and reports to ensure compliance with strict quality standards
  • Providing technical support and facilitating the successful execution of Design Changes for mechanical surgical devices
  • Supporting Design Verification and Validation activities, including review of verification & validation protocols and reports

Required Skills and Qualifications

  • Bachelor of Science degree in a technical discipline (Mechanical Engineering or Biomedical Engineering preferred)
  • Prior experience with implants or instruments products required
  • Minimum of 2-3 years of quality engineering or related experience in an FDA regulated medical device environment
  • Proficiency with medical device development life cycles and Design Control processes

Benefits

  • Competitive salary range: $120,000 - $180,000 per year
  • Opportunity to work with a reputable end-to-end medical device and combination product consulting firm
  • Chance to develop your skills and expertise in quality engineering and medical device development


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