Job Search Results for medical device regulations

Insight Global is seeking a a qualified Top Secret Network Engineer in support of one of are large federal clientsat Langley AFB. This candidate will be supporting and be responsible for tier 1 &... More tier 2 personnel, work trouble tickets, integration and troubleshoot any issues with the network. Their day to day will include but is not limited to: *Establish system performance parameters and sample critical network and information processing *Conduct monthly network trend analysis and create monthly reports and graphs *Sort and file network traffic based on source and destination internet protocol (IP) addresses as needed *Establish baseline network configuration and performance parameters in support of unique ISR sensor data *Conduct network analysis to ensure network performance *Support design, installation, and integration of new routers and other equipment on the enterprise *Establish proper data flows between DCGS and other enterprise nodes *Maintain network interface/port configurations, IP routing tables, firewall settings, filter tables, passwords, and performance controls *Maintain version control of the router operating software at Government direction *Establish configuration and modification of device settings protecting the DCGS Security Boundary through Access Lists *Manage and operate software applications at all sites required to conduct network management of the DPA *Respond to hardware and software problems related to DPA equipment *Coordinate with Government leads to optimize Campus Area Network (CAN) routers, switches, and cryptographic devices *Install CAN/WAN equipment and develop and maintain documentation and drawings *Develop and enforce a comply-to-connect standard for the DPA *Review all integration efforts to ensure engineering rigor and security practices are maintained across the DPA and advise Government leadership regarding any possible risks/concerns/improvements *Process and implement all network service request's (NSR) and security approved ports and services requests (PSR) *Perform transition planning, integration, operations and (O&M) of ATM to Carrier Ethernet/OTN, including out-of-band network management *Review requirements provided by the DCGS Program Office to determine bandwidth, performance, and Controlled Interface (CI) settings for establishing network configuration baselines and provide input back to COR or designated representative within 7 days of receiptCompensation:$43/hr to $45hr.Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable laws..We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Job Description: This role is a classic Supplier Quality Engineer position focused primarily on sustaining quality and problem resolution. The Supplier Quality Engineer works closely with the... More Operations Quality team to review supplier-related non-conformities identified during receiving inspections and manufacturing.The role partners directly with suppliers to evaluate issues, drive root cause analysis, implement corrective actions, and improve supplier quality. This position owns supplier communication and ensures issues remain open until fully resolved through SCARs.Secondarily, this role supports supplier qualification activities for new or redesigned components through APQP/PPAP processes as needed.Key ResponsibilitiesReview and process supplier-related non-conformities identified during receiving and in-factory inspectionsWork directly with suppliers to evaluate issues, drive containment, correction, root cause, and preventive actionsInitiate and manage SCARs for supplier-caused quality issues and ensure timely closureCommunicate supplier progress and resolution status to internal teamsPartner with MRB and Operations Quality to review and process quality notificationsSupport supplier qualification and part development activities following APQP / PPAPGuide suppliers on required quality deliverables including process flows, PFMEA, and control plansUse statistical techniques to support process capability and validation activities (IQ/OQ/PQ)Compensation$45/hr ? $47.50/hrExact compensation may vary based on skills, experience, and education.Benefit packages for this role will start on day one of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401K retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

We are seeking a Quality Inspector to support a critical visual inspection initiative for cryogenic storage materials associated with the Raritan, NJ site. This role will focus primarily on 100%... More visual inspection of cryogenic storage bags, with additional responsibilities providing general QC laboratory and operational support. This position is well suited for candidates who are detail-oriented, patient, and comfortable performing repetitive inspection tasks independently in a regulated environment.Visual Inspection (Approximately 50% of Role)?Perform 100% visual inspection of clear plastic cryogenic storage bags used for frozen product storage.?Inspect approximately 2,000 bags per shipment, with shipments occurring twice per month.?Identify and document defects such as tears, punctures, or material irregularities.?Conduct inspections at a dedicated light box inspection station within the warehouse.?Follow established quality procedures and documentation practices.Laboratory & Operational Support (Approximately 50% of Role)?Support general lab operations including: oHousekeeping and organizationoSample handling and managementoAutoclave operation?Perform inventory checks and basic material management tasks.?Conduct basic chemistry activities, such as pH testing, as needed.?Participate in training opportunities as availableWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

We are in the process of starting a new project/program dealing with the optimization of service and repair centers on a global scale to increase efficiencies. Looking for a Quality Engineer who can... More help lead projects for product transfers, decommissioning, and other related activities. This person will be helping with operational activities and technical writing. They should have a quality mindset with strong project management skills and are able to make decisions without much oversight. They will have the opportunity to be the quality representative in discussions with other cross functional teams as well. The ideal candidate would have experience in service and repair along with understanding of supply chain and/or NPI projects.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking Integrated Marketing Manager for one of our Medical Device clients for a direct hire opportunity. This person is expected to come onsite 4x/week in Versailles OH. The... More Integrated Marketing Manager is responsible for Develops and executes communications strategies and marketing programs to support company must-wins and initiatives. Manages projects across all media platforms including project budgets. Uses data to provide direction on campaign optimizations to enhance marketing performance. Manages teammates who develop and execute copy creation, dealer programs, tradeshows, and events. Has a direct line of reporting to the business unit Downstream Marketing Director, with a dotted-line reporting to the Senior Integrated Marketing Manager.ESSENTIAL/PRIMARY DUTIES:? Oversees and prioritizes communications projects including programs, promotions, product launches, digital marketing campaigns, social media, advertising, media relations, awards, trade shows, dealer sales meetings, events, and other assignments as requested.?Develops and manages marketing communications strategies, tactics and plans based on current technological trends and various target audiences.?Meets with key stakeholders, communicating project requirements and objectives.?Oversees, in conjunction with the digital marketing manager, the demand engine information flow of data and execution of its main elements (lead generation, qualification, CRM, marketing automation, nurturing, analytics).?Provides leadership, creates, and maintains project schedules, and collaborates with internal support teammates, while adhering to schedules and implementing deliverables.?Manages the development of marketing materials and ensures cohesive presentations in support of brand guidelines.?Compiles marketing initiative analytics to measure results and optimize performance.?Maintains and manages allocated budgets.?Manages advertising schedule and submissions in support of external publication contract agreements.?Monitors and reviews content marketing efforts with the ability to nurture and repurpose if needed. SECONDARY DUTIES:?Performs other duties as assigned.?Interacts with sales, marketing managers, distributors, and customers to gain knowledge of market needs for content development.?Schedules, manages, and actively participates in marketing strategy meetings.?Develops contacts and working relationships with vendors and suppliers.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

An employer in the lab consumables/disposables manufacturing industry is looking for a Bilingual Sr. QA Specialist or Bilinguals Quality Assurance Manager to join their team. This role involves... More laying out policies and procedures, with 50% of the time spent at the manufacturing site in Oceanside, only 8 miles away. The individual will interface with customers regarding regulatory and compliance issues, collaborate with other groups, including the QC Manager and Supervisors, and serve as the internal auditor leading audits. Additionally, they will champion the development of other individuals to achieve internal auditor certification. The role will also include responsibilities related to new product development from a QA perspective, customer-related issues, and managing customer surveys/questionnaires, ensuring that responses are communicated effectively. Contributing to the ISO certification of the Oceanside site is also a key focus, as most customers are GMP companies, primarily in the pharmaceutical sector. Some responsibilities of the Sr. QA Specialist or Quality Assurance Manager will include but are not limited to:- Laying out policies and procedures - Customer interface regarding regulatory and compliance - Leading internal audits and championing internal auditor certification for others - Collaborating on new product development processes - Handling customer complaints and investigations - Responding to GMP customer surveys/questionnaires - Championing the 8D investigations and communicating responses back to the customers - Contributing to the ISO certification process for the Oceanside siteWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

This Systems r will manage the verification and traceability of product requirements and specifications for new hardware and software products, aid in product validation planning and execution, and... More analyze/calculate/report on reliability and durability verification activities. The expectation for a Senior Systems / Reliability Engineer is that they regularly serve on the systems engineering team and interact with electrical, mechanical, and firmware engineers to achieve verification goals, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such, they are expected to help identify tasks/resources and fulfill them to ensure that critical project milestones are met and systems integration activities are completed, including reliability testing and statistical data analysis.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

? Cleaning and assembling high-precision optical and mechanical components such as spectrometers, diffraction gratings, miniaturized motor assemblies, ESD sensitive opto-sensors (CCDs and PDAs), and... More electronics boards following work instructions.? Use of epoxy resins, glues, and small machines.? Precise Optical alignments ? Optimizations and testing with automated software and test equipment.Use of PC, Excel, and customer software to record traceability and performance (pass/fail criteria).We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking a Configuration Admin will oversee the implementation of a new configuration management and manufacturing BOM change control process for one of our Supply Chain clients.... More This individual will help with ensuring compliant impact assessments and risk analyses, coordinating with R&D and Quality on implementation, maintaining change records, and reporting metrics to monitor cycle times and support quality initiatives.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking an IT Automation Engineer for a pharmaceutical client in the Raleigh area. The IT Automation Engineer will support the Fill Finish Expansion Project at their greenfield... More facility. These engineers will support the deployment, integration, testing, and troubleshooting of automated assembly and packaging equipment within Finished Products buildings. The role is hands-on and project-focused, supporting OEM equipment, PLC/SCADA systems, MES, serialization, and IT/OT integration in a highly regulated GMP environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less