Biocompatibility & Sterilization Lab Testing Analyst

Position Location US-CA-Rancho Santa Margarita

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Applied Medical develops innovative products that improve patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, we are equally committed to improving the affordability and accessibility of high-quality healthcare. We are proud to have a significant and sustainable impact on healthcare by delivering technologies that enhance clinical care and satisfy the pressing economic needs of our customers. Our Mission is to make a meaningful, positive difference.

Position Description

As a Biocompatibility & Sterilization Lab Testing Analyst, you will be responsible for working within the framework of a team and performing the following activities:

  • Coordinate all testing activities for bioburden, sterility, biocompatibility or other testing programs requiring outside services from a third-party laboratory. Testing will include both routine audits as well as R&D projects
  • Ensure all quarterly, semi-annual, or other regularly scheduled audits are conducted on time
  • Write protocols and final test reports
  • Participate in the analysis and trending of laboratory data
  • Coordinate purchase orders related to laboratory testing
  • Work with team members from engineering and production to collect and send samples for testing
  • Learn and understand the standards and requirements associated with sterilization and biocompatibility
  • Ensure compliance with relevant standards, regulations, and guidance documents
  • Procure standards and ensure these documents are available to Applied team members by maintaining a database
  • Facilitate the gap analysis process by performing gap analyses
  • Contribute ideas and participate in projects to improve efficiency and costs of laboratory tests, while maintaining quality

Position Requirements

This position requires the following skills and attributes:

  • Minimum of 1+ years of work experience in a relevant industry
  • Ability to work independently and as part of a team
  • Positive attitude and embraces constructive change
  • Customer service oriented
  • Ability to multi-task and prioritize projects to align with department and organizational objectives
  • Assertive, not afraid to ask questions
  • Detail oriented, organized, and able to manage testing projects in a fast-paced environment
  • Effective writing, verbal and interpersonal communication skills
  • Must be familiar with computers (Microsoft Office Suite, Adobe Acrobat), copiers and general office equipment
 
As a healthcare company, it is of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We require all new team members to be fully vaccinated (including booster shots, if eligible) upon their start date at Applied Medical (legitimate accommodation requests will be considered). Our current team members have also made this commitment to being vaccinated and receiving the booster shot to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic. Eligibility details to receive the COVID-19 booster shot are provided on the CDC website here.

Preferred

The following skills and attributes are preferred:

  • Bachelor's Degree in physical or biological sciences
  • Experience with medical devices 

Benefits

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental coverage
  • Education reimbursement program
  • 401(k) program with employer match
  • Generous vacation accrual and paid holiday schedule

     

     

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

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