Quality Assurance Engineer II

3 weeks ago


Warren, Ohio, United States Cooper Companies Full time

Cooper Companies is seeking a highly skilled Quality Assurance Engineer II to join our team. As a Quality Assurance Engineer II, you will be responsible for ensuring the quality of our medical devices and processes.

The ideal candidate will have a strong working knowledge of 21CFR820, ISO13485:2016, and ISO14971. They will also have experience in process validation, including IQ/OQ/PQ/TMV/MSA, and be able to analyze information and come to conclusions based on presented data.

Additionally, the candidate will have strong organizational and interpersonal skills, as well as the ability to communicate effectively both orally and in writing. A background in statistics with respect to process control is also preferred.

The successful candidate will be able to work independently and as part of a team, and will have a strong commitment to quality and customer satisfaction.

As a Quality Assurance Engineer II at Cooper Companies, you will have the opportunity to work on a wide range of projects and contribute to the development of new processes and procedures.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Responsibilities:

  • Ensure the quality of medical devices and processes
  • Develop and implement quality control procedures
  • Analyze data and make recommendations for process improvements
  • Collaborate with cross-functional teams to resolve quality issues
  • Develop and maintain quality documentation

Requirements:

  • BS degree in Life Science, Engineering, or equivalent program
  • At least 5 years of experience in the medical device industry
  • Strong working knowledge of 21CFR820, ISO13485:2016, and ISO14971
  • Experience in process validation, including IQ/OQ/PQ/TMV/MSA
  • Strong organizational and interpersonal skills
  • Ability to communicate effectively both orally and in writing
  • Background in statistics with respect to process control

We are an equal opportunity employer and welcome applications from diverse candidates.



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