Postmarket Surveillance Specialist III

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

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