Senior Quality Systems Lead - QMS, Arena, FDA Medical Devices
$120k - $160kSynchron
A leading medical device company in New York is seeking an experienced Senior Quality Systems Specialist. The role involves managing Document Control processes, administering the Arena eQMS, and driving quality system development. Ideal candidates will have over 5 years of experience in FDA regulated industries and a strong knowledge of medical device regulations. This position offers a salary range of $120,000 to $160,000 along with comprehensive benefits and a culture focused on quality and collaboration. #J-18808-Ljbffr Synchron
- ...seeking a strategic and hands-on Senior Manager, Quality Systems to design, implement, and lead a scalable Quality Management System... ...and QC, ensuring products meet FDA OTC, cosmetic GMPs, ISO 22716,... ...track record of building robust QMS and leading #J-18808-Ljbffr Supergoop...QualitySenior
$120k - $160k
...seeking an experienced Senior Quality Systems Specialist to... ...System (QMS) and contribute to... ...experience working within FDA regulated industries (preferably medical devices) and who have... ...eQMS (preferably Arena). The ideal candidate... ...ISO 13485:2016 Lead Auditor...QualitySeniorMedical deviceFull timeTemporary workFor contractorsInternshipFlexible hours$130k - $200k
...as prescription medical treatments for... ...medical needs. As a leading innovator of... ...proven, FDA-regulated prescription... ...Management System (ISMS) to maintain... ...with Quality and Regulatory... ...Management System (QMS) documentation,... ...such as medical devices, pharmaceuticals...QualityMedical devicePermanent employmentTemporary workWork at officeLocal areaVisa sponsorshipFlexible hours- ...Validation Consultant to help define, implement, and maintain computer systems validation (CSV) and validation assurance across GxP-regulated... ...for life sciences clients. You will collaborate with business, quality, and IT teams to align validation with regulatory expectations,...QualitySenior
- ...medicine is seeking a hands-on QA/RA Manager to lead Quality and Regulatory operations in New Jersey. The role requires 5+ years of QA/RA experience in medical device manufacturing, oversight of QMS in compliance with FDA regulations, and successful handling of audits....QualitySeniorMedical device
$157.1k - $212.6k
As a Senior Quality Engineer, you will own and drive quality systems across the full hardware development... ...systems (QMS) appropriate for... ...leadershipReliability & Compliance- Lead or support DFMEA/... ..., robotics, medical devices, or similar)-... ...PLM/QMS tools (Arena, ETQ, Greenlight...QualitySeniorMedical deviceContract workFor contractorsFlexible hours$120k - $135k
A leading Contract Development Manufacturing Organization is seeking a Senior Quality Systems Application Analyst to enhance cloud-based quality applications. In this critical role, you will provide technical project leadership, conduct software testing, and ensure system...QualitySeniorRemote jobContract workFlexible hours- A leading global marketing agency is seeking an Associate Director, AI Engineer in New York to develop innovative... ...LLM frameworks, focusing on designing multi-agent systems and collaborating with teams to deliver high-quality AI solutions. The candidate will engage in hands-...QualitySenior
$117.2k - $313.7k
...your career at the company leading workforce transformation... ...Salesforce.Distributed Systems Software Engineer - Public Cloud (Senior/Lead/Principal) Note: By... ...and ship high-quality, production-grade software... ...including: time off programs, medical, dental, vision, mental...QualitySeniorFull time- ...one of the largest medical device contract... ...through industry-leading engineering and manufacturing... ...commitment to quality, service, and innovation... ..., and/or control systems. Has critical... ...Management Systems (QMS), Environmental Management... ...Administration (FDA) regulations,...QualityMedical deviceContract workImmediate startShift work
- ...today and address the medical challenges of... ...Job Description The Senior Manager, Regulatory Affairs... ...US & Canada Strategy Lead - Aesthetics Device is responsible for the... ...with Health Authority (FDA) for key projects/... ...product strategy and the Quality Dossier Program (QDP)...QualitySeniorMedical device
- ...Redwood City locations.As a Senior Quality Engineer, you will:Lead verification,... ...and maintenance of host systems supporting Tempus Medical Device(s).Lead risk assessments... ...accordance with the FDA Quality System Regulation... ...device software (QMS) ISO 13485:2016, FDA 2...QualitySeniorMedical deviceFull timeWork at officeRemote work3 days per week
- Venture Medical, LLC, a leading wound-care company, is seeking a full-time Senior Collections & Recovery Lead to join our growing team... ...experience in wound care, medical devices, or an adjacent industry and... ...documented collection cadence Quality of escalation recommendations...QualitySeniorMedical deviceFull timeWork at officeRemote work
- Katalyst CRO is seeking a Senior Business Analyst for Veeva Vault Quality Docs/QMS in the Life Sciences domain. You will gather requirements, write user stories,... ...and IT teams to ensure compliant, scalable solutions. Lead workshops, validate scope, and drive end-to-end...QualitySenior
- EnerSys is seeking a Senior Field Service Technician IV to join our Energy Systems team. This on-site role requires expert installation... ...mentor junior technicians and lead small to mid-scale field... ...customers and internal teams to ensure quality service. You must bring 5+ years...QualitySenior
- The Manager, Quality Systems & Change Management is responsible for the... ...Quality Management System (QMS) and associated Change Management... ...systemic quality concerns. Lead or support investigations... ...leadership experience. Preferred Medical device or other regulated industry...QualityMedical deviceTemporary workImmediate start
- ...Its DEXTER® robotic surgical system empowers more surgeons and sites... .... SFDC Roadmap & Delivery: Lead the on‑time end‑to‑end... ...exposure to ERP systems (QAD) and Quality Management tools (Trackwise)... ...in a regulated environment (Medical Device or MedTech preferred) with specific...QualitySeniorMedical deviceWork at officeFlexible hoursShift work
- ...Digital Space LLC seeks a Product Quality Sr Designer to refine documentation... ...regulatory alignment for new and existing medical devices. You will influence system design, testing, and risk... ...groups to maintain DHF content, ensure FDA/ISO compliance, and address cybersecurity...QualitySeniorMedical device
$88.6k - $246.6k
...Solution Implementation Lead is the end‑to‑end... ...operationalization of new connected medical device and digital health... ...into clear device, system, service, and validation... ...Solution‑Level Readiness, Quality & ComplianceEnsure... .... Working knowledge of FDA guidelines and global regulatory...QualityMedical deviceFull timePart timeImmediate startRemote workWorldwide- ...! is seeking a strategic and hands-on Senior Manager, Quality Systems to build, implement, and lead a robust, scalable Quality Management System (QMS) across our product lifecycle. This role... ...Management System aligned with FDA OTC requirements, cosmetic GMPs (21 CFR...QualitySeniorContract work
$108k - $145.07k
Overview As a Senior Procurement Lead at Linesight, you will work with highly experienced, culturally... ...Utilise client specific procurement systems and processes as required , ensuring... ...within the pharmaceutical/medical device sectors or from an EPC background in...SeniorMedical deviceContract work- ...Supplier Audit and GxP system Periodic Reviews.... ...issues/risk to senior leadership. Plan,... ...with Technology Quality and Business Quality... ...identified gaps. Leads the resolution of... ...Systems and software medical devices. Auditor... ...regulatory agencies, e.g., FDA, MHRA, TGA,...QualityMedical device
$150k - $170k
...harnessing Danaher’s system of continuous improvement... ...commitment to quality, and a collaborative spirit... ...everything possible.The Senior Program Manager will... ...have the opportunity to:Lead Program and Project... ...biotechnology, pharmaceutical, or medical device related field required...QualitySeniorMedical deviceFull timeRemote workWork from homeFlexible hours- 42403 Senior Growth Leader, Healthcare Cephas Consultancy Services Private Limited New... ...providers, payers, pharmaceutical companies, medical device organizations, life sciences, and... ...business role. You'll focus on acquiring high-quality, scalable clients, then hand engagements...QualitySeniorMedical deviceHourly payFull timeLocal area
- ...proprietary operating system, Alli—to deliver cutting... ...maximize the efficiency and quality of the team to ensure... ..., and performance to senior-level clients via... ...professional growth by leading by example and nurturing... ...and support for everyday medical expenses and routine care...QualitySeniorContract workWork experience placementLocal area
- Menarini Stemline is seeking an External Quality Lead to provide tactical quality oversight of... ...with cGMP and company quality systems. The role requires 6-8 years in Quality... ...manufacturing experience and a strong grasp of FDA/EU regulations. #J-18808-Ljbffr Menarini...QualitySenior
- Jobtailor in New York seeks a senior leader to own the Quality Management System (QMS), document control, and training in a biotech setting. You will serve as the eQMS SME, ensuring system performance, compliance, and continuous improvement across SOPs, records, and training...Quality
- ...experts in health tech, hospital systems, academia, and clinical AI. We... ...AI developers, pharma, and medical devices, while raising the bar for patient safety and data quality. Tomorrow, we will be the place... ...offering tailored solutions Lead without authority, driving and...QualitySeniorMedical deviceRemote workFlexible hours
- ...Young in New York partners with a global CDMO to expand their QA team. The Senior QA Specialist will review documents, protocols, qualifications and reports within the Quality Management System and may participate in regulatory inspections and client audits. You'll collaborate...QualitySenior
- ...help shape software quality practices across a... ...is seeking a Senior Staff Software Quality... ...provide quality-system guidance throughout... ...process gaps and lead continuous-improvement... ...ISO 27001, HIPAA, FDA, and other... ...preferably within medical devices, digital health, healthcare...QualitySeniorMedical deviceFull timeFor contractorsRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Quality Systems Lead - QMS, Arena, FDA Medical Devices. Be the first to apply!
- srs distribution New York, NY
- senior operations coordinator New York, NY
- senior associate architect New York, NY
- senior revenue operations analyst New York, NY
- senior dynamics crm developer New York, NY
- senior application security New York, NY
- senior account director New York, NY
- sr hr business partner New York, NY
- senior supervisor New York, NY
- senior plumbing designer New York, NY

