The Associate Director, MFG Training, Compliance and OpEx
Northbridge or Watertown
$150k-$190k/yrHybridFull Time
EyePoint PharmaceuticalsNASDAQ: EYPT: Clinical-stage developing sustained-delivery treatments for retinal diseases.
Lead design and improvement of manufacturing training, regulatory compliance (FDA, EMA, ISO), and Operational Excellence using Lean and Six Sigma across multi-site manufacturing.
Ahlstrom: Manufacturer of sustainable fiber-based specialty materials.
Lead product development for medical films and nonwovens, oversee design transfers, manage projects and trials, understand film chemistry and FDA/ISO awareness, and travel as needed.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams
ThermoSafe: Manufacturer of temperature-controlled packaging solutions for cold chain logistics.
10+ YOEBachelor's degree or equivalent experience,10+ years manufacturing leadership,budget and capital project experience,lean/continuous improvement and safety leadership,experience with FDA/GMP preferred.
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yrOnsiteFull Time
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
5+ YOEBachelor's degree or equivalent and 5+ years relevant experience; leadership and coaching skills; knowledge of safety, quality, FDA/GMP/ISO/OSHA; proficiency with SAP, MES and Microsoft Office.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP, MES
Sheffield Pharmaceuticals: Manufacturer of over-the-counter pharmaceuticals and personal care products.
1+ YOEBachelor's in chemistry or related field, analytical/QC lab experience (1+ year preferred), familiarity with cGMP/OSHA/FDA compliance, instrument qualification/calibration, documentation and safety procedures.
ICU MedicalNasdaq: ICUI: Develops and manufactures medical devices for infusion and critical care.
2+ YOEBachelor's in Engineering/Technology/STEM, 2 years' medical device or engineering experience, knowledge of injection molding, automation, Six-Sigma methods, FDA QSR, SolidWorks, and technical writing.
Part-time- temporary Food Inspector (CT, South Windsor)
South Windsor, Connecticut, United States
$35/hrFieldPart Time, Temporary
Town of South Windsor: Provides local government services and municipal administration to residents.
Conduct inspections of licensed food establishments to ensure compliance with the FDA Food Code and local health ordinances; flexible hours including evenings/weekends; mileage reimbursed for travel between inspections.
KARL STORZ: Developer and manufacturer of endoscopic medical equipment.
5+ YOE1+ Mgmt5+ years warehouse/logistics experience, 1+ year supervisory experience, regulated environment experience (FDA/ISO/GMP/GDP), SAP/ERP/TMS/WMS proficiency, strong communication and problem-solving.
Putnam Plastics Corporation: An industry-leading manufacturer of medical device components focused on quality and continuous improvement.
2+ YOE2+ years QC or laboratory experience in manufacturing/medical, knowledge of ISO/FDA/cGMP and good documentation practices, strong leadership, ability to read engineering drawings and SDS, high school diploma or equivalent.
Trinity Health: National Catholic health system providing comprehensive clinical medical services.
Requires active RN license, bachelor’s degree in nursing/healthcare or related (master’s preferred), experience in medical risk management and leadership preferred, knowledge of Joint Commission, FDA, OSHA, and strong communication skills.
Cirtec Medical: Outsourced design and manufacturing for complex medical devices.
3+ YOEHigh school/GED required, 3+ years in engineering/manufacturing for medical devices, knowledge of FDA cGMP and ISO 9001/13485, fluent English. Familiarity with Pro-E/CREO or SolidWorks and DMAIC is a plus.
Yale University: Providing higher education and conducting advanced scientific research.
3+ YOEGraduate of an accredited nursing program with a minimum of 3 years related nursing or clinical research nursing experience; strong clinical, analytical, organizational skills; knowledge of FDA/ICH/GCP; Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Clinical Trials Management Systems (CTMS), Beacon
Celldex TherapeuticsNASDAQ: CLDX: Developing antibody-based immunotherapies for inflammatory and autoimmune diseases.
5+ YOEBA/BS required; 5+ years clinical data management experience; proficiency in Medidata Rave; knowledge of CDISC and FDA regulations; strong Excel/Word/Outlook skills; excellent communication and organizational abilities.
Medidata Rave, Microsoft Excel, Microsoft Word, Microsoft Outlook
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
4+ YOEBachelor's in engineering plus 4+ years relevant experience (or advanced degree with reduced experience). Experience with PLCs, robotics, vision systems, PCB/firmware, NFPA/OSHA/FDA compliance, equipment validation, and failure analysis.