Lead Document Controller - Medical Devices & QMS
Aurora Lifesciences
Aurora Lifesciences is seeking an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment. The role ensures documents are accurate, approved, traceable and available, supporting ISO13485 compliance and regulatory requirements. You will partner with Quality, Regulatory, Manufacturing and Engineering teams, oversee change control, document lifecycle, audits, and training; supervise junior staff and drive process #J-18808-Ljbffr Aurora Lifesciences
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Lead Document Controller - Medical Devices & QMS in Brooklyn, NY vacancy
- ...Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-... ...framework for a portfolio of assay based medical device products. This role establishes standardized... ...within the Quality Management System (QMS). Ensure the team maintains a state of...Medical deviceWork at office
RXinsider
Brooklyn, NY3 days ago - ...that is looking for an experienced Senior Document Controller to manage controlled documentation and... ...compliance. Reviewing batch records, device history records or equivalent product documentation... ...Systems or document control within medical devices, pharmaceuticals or another...Medical device
Aurora Life Sciences Inc
Brooklyn, NY3 hours ago - ...Manage document control process for new and revised procedures within the QMS. Maintain training matrix and ensure training assignments... ...completion. Identify and lead improvements to QMS, document... ...experience working in the medical device industry, Quality Assurance,...Medical deviceWork at office
Dornier MedTech
Brooklyn, NY1 day ago $142k - $213k
...Quality Systems and Compliance Lead drives quality excellence at... ...health, research tools, and medical devices are developed, commercialized... ...the Quality Management System (QMS) — spanning consumer,... ...action plan, predetermined change control plans).* Maintains and advances...Medical deviceFull time- ...is currently seeking a Document Control Specialist position... ...will be eligible for Medical, Dental, 401K and a variety... ...Specialist - Medical Devices (Design Control &... ...quality management system (QMS) requirements, and... ...industry pioneer to a leading workforce solutions provider...Medical deviceFull timeContract workTemporary workWork experience placementWork at officeLocal areaRemote work
- Telamon is a leading provider of connectivity integration, implementation... ...: Health & Wellness: Medical, dental, vision, HSA with... ...Job Summary: The Specialist, QMS Documentation is responsible for creating, preparing, managing, and controlling quality and certification...Hourly payDaily paidCasual workWork at officeLocal areaRemote workFlexible hoursShift work
- Kelly Services is seeking a Document Control Specialist to support medical device development in Blue Ash, OH. The role involves managing design control documentation, processing change orders, and ensuring QMS compliance throughout the product lifecycle. The ideal candidate...Medical deviceFull timeContract work
- Edwards Lifesciences is seeking a CAPA Manager to lead and continuously improve the Corrective and Preventive Action program within a regulated medical device environment. This role owns governance, drives CAPA execution, and partners with cross-functional teams to prevent...Medical device
- Siemens AG is seeking a senior Solution Manager for the Medical Devices sector within the Life Sciences Industry team. The role focuses on defining and delivering differentiated solutions that integrate engineering and manufacturing software with automation, working with...Medical device
- MiniMed in California is seeking a Labeling Program Manager to lead large-scale labeling initiatives ensuring quality, compliance, and patient safety across a highly matrixed organization. You will serve as an SME on labeling and technical literature, drive process improvements...Medical device
- QuidelOrtho is seeking a Quality Lead, Requirements and Specifications Management (Assay) to design, implement and continuously improve... ...end-to-end requirements and specifications for assay-based medical devices in a global role. You will work with R&D, Systems Engineering,...Medical device
- Innolitics LLC is a remote-first medical device consultancy hiring a Senior Regulatory Affairs Specialist to lead regulatory engagements for AI/ML-enabled SaMD. You will shape regulatory strategy, advise on FDA AI/ML framework, and drive Fast 510(k) sprints to completion...Medical deviceRemote job
- ...MA is seeking an experienced QMS leader to ensure compliance... ...requirements. You will own document control, CAPA, supplier qualification... ...requires extensive experience in medical devices, strong audit capabilities,... ...record in training and leading teams. You will drive metrics...Medical device
- Telamon Corporation seeks a qualified Specialist, QMS Documentation to create, manage, and control quality documentation supporting the company’s QMS. You will ensure SOPs, work instructions, and certification packages are accurate and compliant, coordinating with Quality...
- ...and product lifecycle management for a neurovascular portfolio. You will evaluate product changes, prepare submissions, maintain documentation, and guide cross-functional teams to meet market access requirements. Onsite work is expected to collaborate across functions....Medical device
- Verily Health seeks a Quality Systems and Compliance Lead to own QMS across consumer, research, and medical device domains, including SaMD and AI/ML products. The role requires building robust quality frameworks, leading regulatory alignment, and driving CAPA and continuous...Medical device
- American Society for Quality in Kentucky seeks a hands-on Quality Manager to lead the ISO 13485 QMS for a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive...Medical device
- ...senior quality leader to oversee inspection functions in the Quality department, directing workload and ensuring adherence to medical device standards. The role includes training inspectors, maintaining timecards, and ensuring standard work is followed across teams. You...Medical device
- Apple seeks a Senior Lead Auditor in Cupertino to lead a risk-based internal and supplier audit program ensuring regulatory compliance for medical device features in our Health group. You will conduct audits against ISO 13485, MDSAP, EU MDR and other international standards...Medical device
- .... The role partners with the CQO and senior leaders on regulatory shifts (FDA, ISO) and mitigates complex compliance risks for medical devices and companion diagnostics. As a near-site hybrid role, candidates should be located near one of Quest Diagnostics hub locations...Medical deviceShift work
- Trinity Life Sciences is seeking driven Senior Consultants to lead multiple case teams and mentor junior staff in the life sciences... .... The role spans strategy design and implementation across medical devices, diagnostics, and digital health, with exposure to cardiovascular...Medical device
- Dexcom Inc. seeks a senior program leader to direct platform programs for wearable biosensor technologies, spanning research, development, and verification & validation from feasibility through commercialization. You will coordinate with platform and product teams on V&...Medical device
$23 - $24 per hour
...alternative application process. Manufacturing Lead Full Time San Diego, CA, US 2 days ago... ...Lead produces standard and/or custom medical devices to meet customer requirements by... ...quality levels are maintained. Complete all documentation and training as required. Assist in...Medical deviceHourly payFull timeFor contractorsAfternoon shift- Skyhawk Therapeutics, Inc. is seeking a Documentation Specialist, Quality Assurance to provide QA support across regulated operations... ...SOP development, training administration, and document control within Veeva QMS. Ideal candidates have a life sciences degree and at...
$150k - $215k
...based procedures into at-home care via device-enabled therapeutics. Indomo’s lead program couples a proven... ...execute the Chemistry, Manufacturing & Controls (CMC) strategy and operations for Indomo... ..., and manufacturing with the medical device component of Indomo’s drug delivery...Medical deviceLocal area- ...Junior Product Complaints Engineer to join a dynamic Medical Device R&D environment in Manchester, NH. You will review complaints and perform evaluations, ensuring documentation aligns with FDA regulations and QMS requirements. You will work with cross-functional teams...Medical device
- ...will wow your world! Responsibilities: Leads and directs the daily activities of all... ...segregated dispositioned per MRB. Tests and controls WIP, raw material and finished product... ...related roles. Comprehensive knowledge of medical device regulations and quality systems (e.g.,...Medical deviceWork at office
- Textile Manufacturing Lead Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex Manufacturing... ...or downstream customer requests. Work inside a controlled clean room environment for material finishing,...Medical deviceContract workFlexible hoursNight shift
- ...Clinical Diagnostics, creating a world‑leading in vitro diagnostics company with award... ...quality/delivery/service including supplier controls, leading the development of the... .../ Procurement Management experience in medical device and/or a regulated manufacturing environment...Medical deviceContract workWork at officeRemote workShift work
- Stanley Black & Decker, Inc. is seeking a Quality Manager to lead the onsite quality function in Allentown, PA. You will establish and maintain the ISO 9001-compliant QMS, promote awareness, and drive corrective actions with cross‑functional teams. The role requires a bachelor...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead Document Controller - Medical Devices & QMS. Be the first to apply!
Related searches
- document reviewer Brooklyn, NY
- document administrator Brooklyn, NY
- temporary file clerk Brooklyn, NY
- documentation associate Brooklyn, NY
- document control associate Brooklyn, NY
- document clerk Brooklyn, NY
- document control assistant Brooklyn, NY
- document control specialist Brooklyn, NY
- document production specialist Brooklyn, NY
- legal document specialist Brooklyn, NY