Quality Systems Lead: ISO 13485 & FDA Readiness On-Site
Australia-Employment
Australia-Employment is seeking a Quality Systems Manager in Parsippany, NJ. This role entails leading and improving the Quality Management System (QMS) compliant with ISO 13485 and FDA regulations. The ideal candidate has over 10 years in medical device quality systems and proven experience implementing ISO standards. Key responsibilities include managing regulatory registrations, leading audits, and developing quality training initiatives. The position offers comprehensive benefits including medical, 401(k), and tuition reimbursement. #J-18808-Ljbffr Australia-Employment
$160k
...: My client is a leading Medical Device Manufacturer... ...are looking to add a Quality Systems Manager who will be... ...) in alignment with ISO 13485, 21 CFR Part 820, and... ...certification and managed FDA Establishment... ...activities for manufacturing sites. Why join us?...QualityWebsiteTemporary workLocal areaFlexible hours$155.83k - $170k
...need leaders and experts ready to shape what’s next. As a Medical Lead, you’ll bring your... ...shapers of health care systems Strong knowledge of FDA regulations and processes... ...to enable delivery of quality medical and strategic... ...-class manufacturing sites and 4 specialized...QualityWebsiteFull timeLocal areaWorldwide$120k - $170k
...CooperSurgical is a leading fertility and women’s... ...Manager, Global CAPA System is responsible for the... ...1 CFR Parts 210/211, ISO 13485, the FDA Quality Management System Regulation... ...all regions and sites. This role provides... ...and enhance inspection readiness. Act as CAPA lead...QualityWebsiteWork at office- ...clinical data and adherence to quality standards. 4. Monitors... ...with continual accreditation readiness and evaluates practice schedule... ...patients through the health care system and helps patients arrive at... ...Surrogacy Leave * Backup and On-Site Childcare * Well-Being Rewards...QualityWebsiteHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorFlexible hours
- ...Lead Structured Cabling Technician The Lead Structured Cabling... ...testing of structured cabling systems for Wi-Fi Access Point (AP) installation... ...manager to meet deadlines and quality benchmarks. Key... ...manager, network engineers, and site supervisors to report progress...QualityWebsiteFor contractorsLocal area
$130.7k - $196.1k
...sustainable supply of quality products emerges from the... ...OT) Strategy Leader to lead the digital... ...maintenance, and control systems teams. The OT Strategy... ...in collaboration with site personnel. Develop and... ..., scalable, and future‑ready OT infrastructure. Facilitate...QualityWebsiteTemporary workWork experience placementFlexible hours$100k - $125k
Ferring Pharmaceuticals Inc. is hiring a Senior Technical Associate, Quality Assurance in Parsippany, NJ. This role ensures compliance with cGMP regulations and involves reviewing quality system documents, supporting audits, and mentoring QA staff. Candidates should have...Quality- ...are set high. If you're ready to shape the future of... ...team that believes in quality, care, and community —... ...next Full-Time Packaging Lead will be responsible... ...This position will be on-site at our Boonton, NJ facility... ...affect the respiratory system, eyes, or skin,...QualityWebsiteFull timeContract workLocal areaImmediate startFlexible hoursShift workAfternoon shift
$37.69 - $47.12 per hour
...Lead Xray Imaging Technologist ****$5,000 SIGN ON BONUS**** Bonus... ...schedules at your respective sites on W2W, coordinating with the... ...acceptable time frame. Produces quality diagnostic images for... ...minimize anxiety. Operates system and imaging equipment properly...QualityWebsiteHourly payFull timeWork at officeLocal areaRelocation packageMonday to Friday$24 - $28 per hour
...step in immediately — and lead the way. That someone... ...: With standardized systems, we deliver consistency... ...residential and commercial job sites Respond to emergency... ...Technicians to uphold quality and safety standards... ...and equipment use Ready to Join Us? We are...QualityWebsiteHourly payFull timeLocal areaImmediate startRelocation package- ...This position ensures optimal patient safety, quality outcomes, and customer service. Principal... ...in Morristown, New Jersey, we are one of the leading non-profit health care systems in the nation. Our facilities and sites of care include: Atlantic Health Morristown...QualityWebsiteHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorFlexible hoursShift work
$90k - $120k
...CooperSurgical is a leading fertility and... ...Livingston, NJ (on-site) Scope The Product... ...10, 211, 820, and ISO 13485. This role ensures... ...for investigation quality, prioritization, escalation... ..., and inspection readiness, while driving... ...Management System processes based on...QualityWebsiteContract workWork at office$155k - $165k
Principal Quality Internal Auditor Location... ...days at home (site based) Salary... ...vital role in leading and... ...not limited to ISO 13485, ISO 14971, 21... ...audits of quality systems and processes to... ...Participate in and lead FDA and Notified... ...to drive audit readiness and regulatory...QualityWebsiteTemporary workWork at officeRemote workWork from homeFlexible hours$80k - $110k
...running! Dedicated to innovation, quality and excellence, we deliver cutting edge control systems for the Aerospace & Defense... ...Initiatives. Experience with AS9100 and ISO standards. Exemplary verbal/... ...improvements/changes. Lead/oversee the investigation, assessment...QualityWebsiteLocal areaFlexible hoursShift work$18 - $20 per hour
...supports the work of the Y, a leading nonprofit committed to... ...activities that support kindergarten readiness, creativity, physical... ...direction of the Camp Director, Site Director, or assigned supervisor... ...as needed to maintain a high-quality early learning environment....QualityWebsiteHourly paySummer workImmediate start$118.8k - $178.2k
...reliable and sustainable supply of quality products emerges from the... ...and distribution productivity; lead and engage on project teams... ...initiatives. Work closely with finance, site logistics leaders, vendors,... ...technology (Yard Management Systems and Tracking Tools) for...QualityWebsiteTemporary workFlexible hours- ...ensuring adherence to timelines, budgets, and quality standards. Key responsibilities include vendor selection, on-site management, and client communication. The ideal... ...certifications. This position offers the opportunity to lead diverse projects within the telecommunications...QualityWebsite
$130k - $180k
...innovative solutions in site/civil, water/wastewater... ...employee retention. Ready to advance your career... ...years of experience to lead the planning, design, and... ...with water and wastewater system engineering is a... ...relationship continuity, and quality project delivery....QualityWebsiteContract workRemote workFlexible hours- ...Mailroom Site Lead Now is a great time to join our growing company! The Millennium Group (TMG) is an award-winning business process... ...responsible for overseeing on-site operations; productivity, and quality standards are met. This role acts as the primary point of contact...QualityWebsiteWork at office
$77.05k - $143.09k
Quality Learning Systems Specialist The Quality Learning Systems Specialist ensures services, processes, and facilities comply with Quality Assurance... ...Systems. Understanding of external standards such as ISO and Lean Six Sigma for quality in the biopharmaceutical industry...QualityTemporary workWork at officeLocal areaRemote work1 day per week- ...External vendors, Investigational Sites, Investigators of ISSs & ESCs... ....* Supportive of Co-leading the Medical Strategy Team (MST... ...operational excellence and compliance readiness.* Develop and track medical... ...necessary to ensure project quality.* Develop and maintain...QualityWebsiteContract workLocal areaFlexible hours
- Job title: GRA CMC Lead Location: Morristown, NJ About... ...local regulatory teams, quality groups within R&D and... ...including RSO (Regulatory Site Officer) teams, partners... ...of the immune system—and innovative pipeline—... ...Authorities, including the FDA (US) and the EMA (Europe...QualityWebsiteLocal areaWorldwide
- ...Manager, Enterprise Business Systems, to lead the implementation,... ...and support across a multi‑site health system. Lead configurations... ...strong data governance, audit readiness, and internal controls. Identify... ..., security, and data quality. Ensure alignment with enterprise...QualityWebsite
$253.79k - $380.69k
...responsible for defining and leading the enterprise-wide supply chain... ...related to planning systems, analytics, and automation. Demand... ...teams to improve planning data quality, integration, and visibility.... ...SIOP / IBP in complex, multi-site or global environments Demonstrated...QualityWebsiteFull timeWork experience placementWorldwideRelocation packageShift work$80k - $110k
Marotta Controls, Inc. is seeking a Production Supervisor to lead our manufacturing operations in Montville, NJ. You will ensure the Production Cell meets all safety, quality, and productivity targets while overseeing staffing and operations. This role requires strong leadership...QualityFlexible hours- ...SUMMARY The Quality Manager is responsible for leading, governing, and continuously... ...Quality Management System (QMS) to ensure compliance with AS9100, ISO 9001, regulatory, and... ...as a key member of site leadership—driving product... ..., and succession readiness. Own, maintain, and...QualityWebsiteWork at officeAfternoon shift
$69k - $129k
...Description Job Description HVAC Lead Installation Technician... ...We're a company committed to quality service by empowering reliable... ...high velocity air conditioning systems as well as gas and LP fired furnaces... ...basis. · We provide off-site training for advanced training...QualityWebsitePrice workFull timeWork at officeMonday to FridayFlexible hours$33.65 - $62.5 per hour
...operations at our Morris Plains site. As a Manufacturing... ...and manufacturing systems Support installation, setup... ..., and operational quality Collaborate cross-functionally... ...support manufacturing readiness Maintain an inspection-... ...room environment (ISO 8, 7 and ISO 5) areas for...QualityWebsiteHourly payFull timeWork experience placementSecond jobLocal areaRelocation package$115k - $125k
Sr. Quality Engineer (Wayne, NJ) Date... ...days at home (site based) Salary... ..., and quality systems activities,... ...Nonconformance Leadership Lead or support... ...inspection readiness activities... ...working in an FDA‑regulated and/or ISO‑certified environment... ...0 / QMSR, ISO 13485) Reasonable...QualityWebsiteRemote workWork from home$320k - $350k
...Job Description Atlantic Health System is Seeking Dedicated Nocturnists in New Jersey... ...-$350,000 base salary only; excludes any quality and/or productivity incentives Qualifications... ..., Surrogacy Leave ~ Backup and On-Site Childcare ~ Well-Being Rewards ~...QualityWebsiteHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorFreelanceFlexible hours
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