Biocompatibility Reporting Specialist

2 weeks ago


Rancho Santa Margarita, California, United States Applied Medical Full time
Revolutionize Medical Device Manufacturing

At Applied Medical, we're pushing the boundaries of innovation in medical device manufacturing. As a key member of our Biological Sciences department, you'll play a crucial role in ensuring the biocompatibility of our products.

Key Responsibilities:
  • Biocompatibility Evaluation: Conduct thorough analyses of data and interpret results to identify trends and patterns that impact product safety.
  • Attention to Detail: Maintain meticulous records and follow protocols to ensure the accuracy and validity of testing results.
  • Documentation and Reporting: Prepare and review detailed reports on product evaluation, testing procedures, and results to inform regulatory submissions and internal decision-making.
  • Continuous Improvement: Identify opportunities for process enhancement and contribute to the development of best practices within the organization.
  • Risk Management: Collaborate with cross-functional teams to assess and mitigate biological safety risks associated with our products.
Performance Objectives:
  • Initial 30 Days: Complete Applied Learning foundational courses with a passing grade of 95% or above, demonstrate rapid integration into company processes, and participate in team meetings and operations.
  • 60 Days: Exhibit a strong technical understanding of the biological evaluation process, support team meetings and agendas, and take on projects with low to moderate guidance.
  • 90 Days to 1 Year: Develop interpersonal connections and relationships with colleagues to effectively accomplish project objectives, become a subject matter expert in biocompatibility, and review and approve biocompatibility documentation.
Requirements:
  • Education: Bachelor's degree in a relevant scientific field.
  • Experience: Minimum of two years of work experience in a relevant industry, with experience in medical devices and biocompatibility evaluation preferred.
  • Skills: Analytical skills, attention to detail, documentation and reporting, continuous improvement, risk management, and effective communication.

We offer a comprehensive benefits package, training and mentorship opportunities, on-campus wellness activities, education reimbursement program, 401(k) program with discretionary employer match, and generous vacation accrual and paid holiday schedule.

Applied Medical is an Equal Opportunity Employer. We welcome applicants from diverse backgrounds and are committed to creating an inclusive work environment.



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