Senior Medical Safety Quality Specialist

4 weeks ago


Littleton, Colorado, United States Terumo BCT Full time
Job Title: Senior Medical Safety Quality Specialist

At Terumo Blood and Cell Technologies, we are committed to delivering innovative medical devices and solutions that improve patient outcomes. We are seeking a highly skilled Senior Medical Safety Quality Specialist to join our team.

Job Summary:

The Senior Medical Safety Quality Specialist will be responsible for leading the development and implementation of safety and quality strategies for our medical devices. This role will involve collaborating with cross-functional teams to identify and mitigate safety risks, ensuring compliance with regulatory requirements, and providing technical expertise to support the development of new products.

Key Responsibilities:
  • Develop and implement safety and quality strategies for medical devices
  • Collaborate with cross-functional teams to identify and mitigate safety risks
  • Ensure compliance with regulatory requirements, including FDA and ISO 13485
  • Provide technical expertise to support the development of new products
  • Lead investigations into adverse event reports and complaints
  • Develop and maintain technical documentation, including user manuals and instructional guides
  • Collaborate with external stakeholders, including regulatory agencies and healthcare organizations
Requirements:
  • Bachelor's degree in a relevant field, such as nursing, biological sciences, or engineering
  • Minimum 3 years of experience in a regulated industry, with a focus on medical device safety and quality
  • Strong knowledge of FDA and ISO regulations, including 21 CFR 820 and ISO 13485
  • Excellent communication and collaboration skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance

Terumo Blood and Cell Technologies is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees.



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