Keystone Industries: Manufactures dental, medical, and cosmetic healthcare products.
5+ YOEMinimum 5 years QA/ISO experience, cGMP and ISO 13485 knowledge, auditing and complaint handling experience, strong analytical and writing skills, Microsoft Office proficiency, Bachelor's degree preferred or equivalent experience.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, MasterControl
Keystone Industries: Manufactures dental, medical, and cosmetic healthcare products.
5+ YOE5+ years QA/ISO quality system experience, cGMP and ISO 13485 knowledge, auditing and complaint/CAPA experience, strong analysis and writing skills, Microsoft Office proficiency, bachelor’s in technical field preferred.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, MasterControl
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
8+ YOEBachelor's degree in a technical discipline and 8+ years in medical devices, healthcare, life sciences, or regulated industries. Requires complaint trending, surveillance analytics, statistical methods, quality systems, and signal detection expertise.
Adverse Event Reporting Spec II, Temporary (6 months)
Elkton, Maryland, United States
OnsiteFull Time, Temporary
Terumo Medical CorporationTokyo Stock Exchange: 4543: Manufactures and distributes medical devices and healthcare products.
3+ YOESupport post-market surveillance and medical device reporting (MDR) to US and global health authorities; review complaints for reportability, coordinate information requests, maintain MDR logs, assist audits and implement quality system improvements. Requires regulatory knowledge and MS Office proficiency.
Microsoft Office, Document Control software applications