Medical device quality engineer jobs in Passaic, New JerseyCreate job alerts

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Modern Stack Technical Leader-Software Engineer | Healthcare Tech | Midtown NYC On-Site 2-3 days per week Domain Focus: Healthcare, Insurance, Claims, Prescriptions, Medical Devices, Pharma Bonus Knowledge: HL7, FHIR, DICOM About Us: We're building the future of healthcare technology—one elegant, scalable application at a time. Our team is transforming how healthcare data flows across systems, empowering providers, insurers, and patients with smarter tools and seamless experiences. From claims automation to prescription intelligence, our platform is redefining what’s possible in health-tech. Desired Experience/Background: • Architect and build full-stack applications using modern coding tools for mobile-device software app development., • Senior Level experience in full-stack development with modern frameworks: AWS Microservices, React/Typescript, Node.JS; experience laying out and designing apps in addition, • Willing-Able-Ready to work in an independent/self sufficient manor (with access to QA, DevOps and other teams and talent whenever needed); get things done/'figure it out' type mentality, • Experience Designing and coding Applications that handle complex healthcare data (HL7, FHIR, DICOM) and allow end users to easily choose the most suitable app., • Cross collaboration experience with product, design, and data teams to deliver intuitive, secure solutions, • Contribute to technical strategy, creation, design and execution of our core software applications, • A Strong History of working in a hand on coding-technical leadership role (or roles), • Passion for clean code, thoughtful architecture, and solving real-world problems, • Excellent communication skills and a collaborative mindset, • Willingness to work on-site (2-3 days per week) in Midtown Manhattan., • Nice to have: Experience working with healthcare-related data (insurance, claims, prescriptions, devices, pharma)...Familiarity with HL7, FHIR, or DICOM standards is a major plus If you're excited by the intersection of cutting-edge tech and meaningful impact, this is your playground. You’ll be surrounded by brilliant minds, supported by a culture that values autonomy and innovation, and immersed in a domain that truly matters. Very Competitive Salary, Bonus, Benefits and Equity. Call or Apply Today! Company DescriptionGrowing-Company that designs and builds Data Driven Applications for a recession resistant industry--constant demand for our Software...Unique Niche SW Company Providing Data Quality-Speed-Accuracy...Culture of Creating and Utilizing the Best Available Technology in order to Deliver Best of Breed Software and Experiences to our Clients. Help us create Raving Fans!Growing-Company that designs and builds Data Driven Applications for a recession resistant industry--constant demand for our Software...Unique Niche SW Company Providing Data Quality-Speed-Accuracy...Culture of Creating and Utilizing the Best Available Technology in order to Deliver Best of Breed Software and Experiences to our Clients. Help us create Raving Fans!