Quality Assurance Engineer II

4 days ago

Warren, Ohio, United States Cooper Companies Full time
About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals.

We offer a wide range of clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

As a wholly-owned subsidiary of CooperCompanies, we are committed to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

Responsibilities
  • Develop and implement quality assurance processes to ensure compliance with regulatory requirements.
  • Conduct process validation, including IQ/OQ/PQ/TMV/MSA, to ensure the quality and safety of medical devices.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Ensure the preservation of quality requirements during integrations and acquisitions.
  • Present results in a logical and clear manner, and communicate effectively with stakeholders.
Requirements
  • Strong working knowledge of 21CFR820, ISO13485:2016, and ISO14971.
  • Experience in process validation, NCMR, CAPA, change control, and GDP.
  • At least 5 years of experience in the medical device industry.
  • Ability to analyze information and come to conclusions based on presented data.
  • Strong organizational and interpersonal skills.
  • Ability to learn and utilize computer in standard business applications.
What We Offer

We offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits.

Please visit our website to learn more about CooperSurgical and the benefits of becoming a member of our team.

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