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Biocompatibility Reporting Specialist

2 months ago

Rancho Santa Margarita, California, United States Applied Medical Full time
About Applied Medical

Applied Medical is a leading medical device company that has been revolutionizing the industry for over 35 years. Our company has a proven business model and a commitment to innovation, fueled by rapid business growth and expansion. We have earned a strong reputation for excellence in the healthcare field and are dedicated to delivering the highest quality products.

Job Description

We are seeking a highly skilled Biocompatibility Reporting Specialist to join our Biological Sciences department. As a key member of our team, you will be responsible for coordinating and reviewing various types of biological testing in support of our production teams. This involves collaborating with multiple groups within Applied Medical and striving to consistently meet or exceed our customer expectations through our commitment to exceptional work quality.

Key Responsibilities:
  • Analytical Skills: You will analyze data and interpret results, identifying trends and patterns that may be important in determining the biocompatibility of a product.
  • Attention to Detail: You will follow protocols and procedures accurately to ensure the validity of the results and identify the source of problems by reviewing your procedures and methodology.
  • Documentation and Reporting: You will prepare and review detailed reports documenting product evaluation, testing procedures, results, and conclusions, which are crucial for regulatory submissions and internal decision-making processes.
  • Continuous Improvement: You will identify opportunities for process improvement within biocompatibility evaluation & testing procedures and contribute to the development of best practices within the organization.
  • Risk Management: You will contribute to risk management processes by providing expertise on biocompatibility aspects and participating in risk assessments related to biological safety.
Performance Objectives:
  • Within your first 30 days, you will complete all Applied Learning foundational courses with a passing grade of 95% or above, demonstrating rapid integration into company processes.
  • Within 60 days, you will exhibit a strong technical understanding of the biological evaluation process and support team meetings and agendas.
  • Within 90 days to one year, you will develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables, become a subject matter expert in biocompatibility, and handle a variety of projects on your own.
Position Requirements:
  • You will have a Bachelor's Degree in a relevant scientific field.
  • You will have a minimum of two years of work experience in a relevant industry and experience with medical devices preferred.
  • You will have experience with Biocompatibility evaluation, testing, and ISO 10993 standards.
  • You will be able to work independently and as part of a team, have a positive attitude, and be customer service oriented.
  • You will have effective writing, verbal, and interpersonal communication skills and be familiar with computers, including Microsoft Office Suite, Adobe Acrobat, and general office equipment.