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HomeCompaniesEMED Technologies CorporationQuality Assurance and Regulatory Affairs Specialist

Quality Assurance and Regulatory Affairs Specialist

EMED Technologies Corporation · New York, NY, United States · On Site · Active · Rippling ATS

Job facts

FieldValue
CompanyEMED Technologies Corporation
TitleQuality Assurance and Regulatory Affairs Specialist
Normalized title-
Department / teamQuality and Regulatory
LocationNew York, NY, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerRippling ATS
Posted / first seen2024-11-16 / 2026-05-29
Changed / last seen2026-06-06 / 2026-06-06

Related slices

PageWhat it containsOpen
Company jobsActive postings from EMED Technologies Corporation.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through Rippling ATS.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in New York.Open
Department jobsActive postings in Quality and Regulatory.Open
Work model jobsActive On Site postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyEMED Technologies Corporation
Sourceed587a36-a3ba-4d32-8305-a90851d55814
ATS providerRippling ATS

Description

company About EMED Technologies Corporation EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come! In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies. role About the role The position supports EMED’s Quality Management System and ensures compliance of the quality/business systems to applicable regulations, standards, and corporate policies. This position reports directly to the Director of CA/QA/RA. What you'll do Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records. Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records. Lead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records. Support nonconforming product handling and disposition assessments and manage all records. Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records. Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site. Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances. May serve as an Internal/Supplier Auditor and conduct audits per schedule Write new and revise existing QMS standard operating procedures as directed. Review, approve, and maintain device history record files. Identify, initiate, and lead process and compliance improvement as requested. Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities. Support various Quality Assurance activities as assigned under minimal supervision/instruction. Assist with Regulatory Affairs tasks as assigned Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined. Qualifications Bachelor’s degree with desired areas including Science, Engineering or related field. Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries. Knowledge of MS Office Suite (Excel, Word, Outlook) Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure. Ability to work in a self-directed manner and confidently deal with ambiguous issues to drive towards suitable actions.

Full job record

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TitleQuality Assurance and Regulatory Affairs Specialist
Normalized Title
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Location TextNew York, NY, United States
DepartmentQuality and Regulatory
Team
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Remote Policy
CountryUnited States
RegionNY
CityNew York
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First Seen At2026-05-29 07:18:30Z
Last Seen At2026-06-06 08:45:54Z
Last Checked At2026-06-06 08:45:54Z
Last Changed At2026-06-06 08:45:54Z
Inactive At
Source Posted At2024-11-16 15:18:01Z
Source Updated At
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style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Lead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Support nonconforming product handling and disposition assessments and manage all records.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">May serve as an Internal/Supplier Auditor and conduct audits per schedule</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Write new and revise existing QMS standard operating procedures as directed.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Review, approve, and maintain device history record files.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Identify, initiate, and lead process and compliance improvement as requested.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Support various Quality Assurance activities as assigned under minimal supervision/instruction.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Assist with Regulatory Affairs tasks as assigned</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined.</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Qualifications</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Bachelor’s degree with desired areas including Science, Engineering or related field.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Knowledge of MS Office Suite (Excel, Word, Outlook)</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Ability to work in a self-directed manner and confidently deal with ambiguous issues to drive towards suitable actions.</span><span style=\"font-size:12pt;white-space:pre-wrap;\">&nbsp;</span></li></ul>",
      "company": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">About EMED Technologies Corporation</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come!&nbsp; In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.</span></p>"
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Get this page with API

Rendered from the bluedoor Job Postings API. Reproduce it:

GET https://api.bluedoor.sh/job-postings/v1/jobs/52fad6dca74209b4a0c498fc0a949f09e0e14921?include=descriptionJSON
GET https://api.bluedoor.sh/job-postings/v1/orgs/6a02bb5e-2f02-450a-84db-9b7d30b84ab9JSON
GET https://api.bluedoor.sh/job-postings/v1/sources/ed587a36-a3ba-4d32-8305-a90851d55814JSON
GET https://api.bluedoor.sh/job-postings/v1/jobs/52fad6dca74209b4a0c498fc0a949f09e0e14921/eventsJSON