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, 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#LI-USPlease be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers siteor contact us at [emailprotected].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).

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, 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#LI-USPlease be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers siteor contact us at [emailprotected].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).