Quality Engineer II, Medical Devices — PMS Data & Compliance

BD

Tempe (AZ)

On-site

USD 80,000 - 100,000

Full time

14 days+
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Job summary

A global medical technology company in Tempe, AZ is seeking a Quality Engineer II to support Post Market Surveillance activities. This role involves analyzing data to identify safety risks and compliance with global regulations. Candidates should possess a Bachelor’s degree in Engineering, with at least four years of experience in the medical device sector. Proficiency in Power BI and strong problem-solving skills are essential. The position requires working collaboratively with various teams to ensure effective reporting and compliance.

Qualifications

  • Minimum of four years’ experience in engineering or quality engineering within the medical device, pharmaceutical industry.
  • Working knowledge of statistical and risk assessment techniques.

Responsibilities

  • Work with a team to meet the requirements in generating periodic PMS related reports.
  • Analyze and interpret PMS data.
  • Identify gaps and maintain PMS processes in compliance with global regulations.

Skills

Medical device experience working with Class I, II, and III devices
Ability to develop solutions with business impact
Strong interpersonal skills
Problem solving ability
Ability to lead cross functional teams

Education

Bachelor’s degree in Engineering or a technical field

Tools

Power BI
Microsoft Excel

Job description

A global medical technology company in Tempe, AZ is seeking a Quality Engineer II to support Post Market Surveillance activities. This role involves analyzing data to identify safety risks and compliance with global regulations. Candidates should possess a Bachelor’s degree in Engineering, with at least four years of experience in the medical device sector. Proficiency in Power BI and strong problem-solving skills are essential. The position requires working collaboratively with various teams to ensure effective reporting and compliance.
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