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 activitiesIdentify trends, risks, and early signals of potential quality issuesInvestigate metric excursions and support root cause analysis and corrective actionsDevelop and maintain dashboards, metrics, and performance thresholdsCollaborate with cross-functional teams including Quality, R&D, Manufacturing, and Customer SupportSupport continuous improvement initiatives based on data insights and field feedbackPrepare and present data analyses, findings, and recommendations to stakeholdersContribute to regulatory inspections, audits, and quality system compliance activitiesDevelop and maintain procedures, work instructions, and documentationEnsure all activities comply with company quality standards and regulatory requirementsQualifications Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, Biomedical Engineering, Medical Laboratory Science, Biotechnology, or related fieldMinimum 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 dataExperience identifying and mitigating quality-related risksPreferred Experience with statistical analysis, reliability analytics, or SPC methodologiesFamiliarity with FDA and international regulations (e.g., FDA 21 CFR, ISO 13485)Knowledge, Skills, and Abilities Data analysis and critical thinkingStrong communication and presentation skillsAbility to manage multiple priorities and meet deadlinesCollaboration and cross-functional teamworkAttention to detail and quality focusProficiency in Microsoft Office tools (Excel, PowerPoint, Word, Teams)Working Conditions Primarily office-based environmentLimited domestic and international travel may be requiredCompensation 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. 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.Benefits A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine optionsCompany-Provided Life and Accidental Death InsuranceShort and Long-Term Disability InsuranceRetirement Plan including a generous non-discretionary employer contribution and employer matchAdoption AssistanceWellness ProgramsEmployee Assistance ProgramCommuter BenefitsVarious voluntary benefit offeringsDiscount programsParental leavesEEO Statement 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 (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).#J-18808-Ljbffr