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Postmarket Surveillance Specialist III

Biofire

Salt Lake City, UT

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JOB DETAILS
SALARY
$77,900–$86,000 Per Year
SKILLS
Analysis Skills, Biochemistry, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Chemistry, Clinical Laboratory, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Customer Support/Service, Data Analysis, Decision Support, Detail Oriented, Documentation, Employee Assistance Plan, FDA (Food and Drug Administration), FDA Requirements, Field Trials, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Medical Equipment, Metrics, Microbiology, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Performance Analysis, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Product Lifecycle, Quality Metrics, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Reliability Analysis, Reporting Dashboards, Research & Development (R&D), Risk Analysis, Root Cause Analysis, Statistical Process Control, Statistics, Surveillance, Time Management, Trend Analysis, Willing to Travel
LOCATION
Salt Lake City, UT
POSTED
7 days ago

Position Summary

The Specialist, Statistical Process Control (SPC) – Molecular is responsible for monitoring and analyzing quality data across the product lifecycle to ensure product reliability and performance. This role uses data-driven methods to identify trends, detect potential quality risks, and support continuous improvement initiatives.

Working cross-functionally, the Specialist provides insights that support decision-making, investigates quality signals, and contributes to maintaining compliance with regulatory and quality standards.

Key Responsibilities

  • Monitor and analyze quality and performance data across manufacturing, products, and service activities
  • Identify trends, risks, and early signals of potential quality issues
  • Investigate metric excursions and support root cause analysis and corrective actions
  • Develop and maintain dashboards, metrics, and performance thresholds
  • Collaborate with cross-functional teams including Quality, R&D, Manufacturing, and Customer Support
  • Support continuous improvement initiatives based on data insights and field feedback
  • Prepare and present data analyses, findings, and recommendations to stakeholders
  • Contribute to regulatory inspections, audits, and quality system compliance activities
  • Develop and maintain procedures, work instructions, and documentation
  • Ensure all activities comply with company quality standards and regulatory requirements

Qualifications

  • Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, Biomedical Engineering, Medical Laboratory Science, Biotechnology, or related field
  • Minimum 2+ years of relevant experience (or equivalent combination of education and experience)
  • Experience working in a regulated industry (medical device or IVD preferred)
  • Strong analytical and problem-solving skills with the ability to interpret complex data
  • Experience identifying and mitigating quality-related risks

Preferred

  • Experience with statistical analysis, reliability analytics, or SPC methodologies
  • Familiarity with FDA and international regulations (e.g., FDA 21 CFR, ISO 13485)

Knowledge Skills and Abilities

  • Data analysis and critical thinking
  • Strong communication and presentation skills
  • Ability to manage multiple priorities and meet deadlines
  • Collaboration and cross-functional teamwork
  • Attention to detail and quality focus
  • Proficiency in Microsoft Office tools (Excel, PowerPoint, Word, Teams)

Working Conditions

Primarily office-based environment

Limited domestic and international travel may be required

 

The estimated salary range for this role is between $77,900-$86,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 
In addition, bioMérieux offers a competitive Total Rewards package that may include: 
·        A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options 
·        Company-Provided Life and Accidental Death Insurance 
·        Short and Long-Term Disability Insurance 
·        Retirement Plan including a generous non-discretionary employer contribution and employer match. 
·        Adoption Assistance 
·        Wellness Programs 
·        Employee Assistance Program 
·        Commuter Benefits 
·        Various voluntary benefit offerings 
·        Discount programs 
·        Parental leaves 

 #LI-US

About the Company

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Biofire