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Job description
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
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, bioMerieux 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
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BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at (emailprotected), or by dialing 711 for access to Telecommunications Relay Services (TRS).
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.