Postmarket Surveillance Specialist III

Summary

DescriptionPosition SummaryThe 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 ResponsibilitiesMonitor 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 requirementsQualificationsBachelor'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 risksPreferredExperience with statistical analysis, reliability analytics, or SPC methodologiesFamiliarity with FDA and international regulations (e.g., FDA 21 CFR, ISO 13485)Knowledge Skills and AbilitiesData 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 ConditionsPrimarily office-based environmentLimited domestic and international travel may be requiredThe 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 optionsCompany-Provided Life and Accidental Death InsuranceShort and Long-Term Disability InsuranceRetirement Plan including a generous non-discretionary employer contribution and employer match.Adoption AssistanceWellness ProgramsEmployee Assistance ProgramCommuter BenefitsVarious voluntary benefit offeringsDiscount programsParental leaves#LI-US#J-18808-Ljbffr

Job Description

DescriptionPosition SummaryThe 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 ResponsibilitiesMonitor 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 requirementsQualificationsBachelor'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 risksPreferredExperience with statistical analysis, reliability analytics, or SPC methodologiesFamiliarity with FDA and international regulations (e.g., FDA 21 CFR, ISO 13485)Knowledge Skills and AbilitiesData 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 ConditionsPrimarily office-based environmentLimited domestic and international travel may be requiredThe 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 optionsCompany-Provided Life and Accidental Death InsuranceShort and Long-Term Disability InsuranceRetirement Plan including a generous non-discretionary employer contribution and employer match.Adoption AssistanceWellness ProgramsEmployee Assistance ProgramCommuter BenefitsVarious voluntary benefit offeringsDiscount programsParental leaves#LI-US#J-18808-Ljbffr