Quality Control Inspector

QC Inspector -The QC Inspector at NeilMed Pharmaceuticals is responsible for performing in-process and final inspections and supporting supplier audits of pharmaceutical and medical device products at Contract Manufacturing Organizations (CMOs) in China.QC Inspector will play a crucial role in ensuring that NeilMed’s products meet all applicable regulatory, quality, and customer requirements, including compliance with EU MDR 2017/745, ISO 13485, FDA (21 CFR 210/211, 820), Health Canada, ANVISA, TGA, and MHLW/ PMDA requirements.The QC Inspector will work closely with the QA Compliance team and NeilMed’s manufacturing partners to verify product conformity and maintain compliance throughout the supply chain.About NeilMed PharmaceuticalsNeilMed Pharmaceuticals is a recognized leader in nasal care products, including nasal irrigation solutions and saline sprays, as well as medical devices. Founded in 2000, NeilMed has grown to serve millions of customers worldwide, with a commitment to product quality, innovation, and customer satisfaction. As part of NeilMed’s global operations, the QC Inspector will play a critical role in maintaining the company’s high standards for product quality and safety, ensuring that all products manufactured at CMOs meet NeilMed’s requirements.Key Responsibilities:Product Inspection and TestingConduct incoming, in-process, and final inspections of pharmaceutical and medical devices products and raw materials at contracted manufacturing facilities in China, ensuring that products meet NeilMed’s quality standards.Verify product quality against approved specifications, drawings, sampling plans, and international standards.Perform and evaluate CMO’s visual, functional, dimensional, labeling, and packaging inspections using appropriate instrumentation and methodologies.Follow NeilMed’s procedures and regulatory requirements for inspection activities.Document inspection findings, including objective evidence, and classification of defects.Segregate and label nonconforming materials and ensure they are handled per NeilMed’s quality procedures. Regulatory & Standards ComplianceEnsure all inspected products comply with NeilMed Pharmaceuticals quality standards and regulatory requirements, including: EU MDR 2017/745 ISO 13485:2016 FDA 21 CFR Parts 210/211 & 820 Health Canada Regulations (SOR/98-282) ANVISA RDC requirements TGA regulatory requirements MHLW/PMDA requirements (Japan)Confirm accuracy of traceability, Unique Device Identification (UDI), lot/Batch documentation, and Device History Records (DHR).Supplier & Manufacturing OversightConduct routine on-site inspections at CMOs throughout China to assess compliance with GMP and QMS requirements, ensuring adherence to NeilMed’s standards.Review batch records, DHRs, Certificate of Analysis (COA), and Certificates of Conformity.Communicate quality issues to suppliers and NeilMed’s internal QA team to drive timely containment and remediation.Support supplier audits, process validation, first article inspections, and line readiness checks.Documentation control & Records / Supplier auditsCollaborate with CMOs to investigate root causes and define corrective and preventive actions (CAPA).Verify CAPA effectiveness with follow-up inspections, documentation checks, and data reviews.Maintain accurate and compliant records in accordance with GDP.Support regulatory, customer, and internal audits as needed.Qualifications Education Bachelor’s degree in Engineering, Sciences. Minimum 8-10 years of QC/QA experience in pharmaceuticals and medical devices, ideally within manufacturing or supplier oversight environments.Technical Skills Strong knowledge of: EU MDR 2017/745 ISO 13485 & ISO 14971 FDA 21 CFR 210/211 & 820 GMP and GDP principlesExperience with AQL, and statistical sampling plansLanguage RequirementsFluent in English and Mandarin (both written and spoken) is required for effective communication with global customers and China-based manufacturers.CompetenciesStrong attention to detail and analytical mindsetAbility to work independently at multiple supplier sitesExcellent communication, documentation, and cross-cultural collaboration skills.Willingness to travel frequently within China. NeilMed Pharmaceuticals is committed to delivering high-quality nasal care products and medical devices to customers worldwide. By joining our team, you’ll help ensure that every product reflects our dedication to safety, quality, and regulatory excellence.