Description

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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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).