Job Search Results for process engineer

This position is essential to driving CAPA activities from issue identification closure, project manage CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during... More audits and CAPA review board meetings. Position to be home based in the USA. Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.?Screening Questions and Answers:1.What does CAPA stand for, and why is it important in the medical device industry?oCAPA stands for Corrective and Preventive Actions. It is crucial in the medical device industry to identify and eliminate the root causes of non-conformities and prevent their recurrence, ensuring product quality and regulatory compliance.1.Can you explain the difference between corrective actions and preventive actions?oCorrective actions address existing issues by identifying and eliminating the root cause of a non-conformity. Preventive actions are proactive measures taken to prevent potential issues from occurring.1.Process and Implementation1.What are the typical steps involved in a CAPA process?oThe typical steps include: identifying the issue, conducting a root cause analysis, developing a corrective/preventive action plan, implementing the actions, verifying the effectiveness, and documenting the entire process.1.How do you identify when a CAPA is needed?oA CAPA is needed when there is a significant non-conformity, customer complaint, audit finding, or any other indication of a systemic issue that could impact product quality or regulatory compliance.1.What tools or methods do you use for root cause analysis in CAPA investigations?oCommon tools include the 5 Whys, Fishbone (Ishikawa) Diagram, Failure Mode and Effects Analysis (FMEA), and Pareto Analysis.1.Regulatory Compliance1.Which regulatory standards and guidelines must CAPA processes comply with in the medical device industry?oCAPA processes must comply with FDA?s 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Medical devices ? Quality management systems).1.How do you ensure that CAPA activities meet FDA and ISO 13485 requirements?oBy following a structured CAPA process, maintaining thorough documentation, conducting regular audits, and ensuring all actions are traceable and verifiable.1.Practical Application1.Can you provide an example of a CAPA you have managed, including the issue, investigation, and resolution?oExample: A non-conformity was identified in a batch of medical devices due to a manufacturing defect. A root cause analysis revealed a malfunctioning piece of equipment. The corrective action involved repairing the equipment and retraining staff. The preventive action included implementing regular maintenance checks. The effectiveness was verified through subsequent batch testing.1.How do you verify the effectiveness of a CAPA once it has been implemented?oBy monitoring the process or product for recurrence of the issue, conducting follow-up audits, and reviewing performance data to ensure the issue has been resolved and does not reoccur.1.Continuous Improvement1.What role does CAPA play in continuous improvement within a quality management system?oCAPA is integral to continuous improvement as it systematically addresses and eliminates root causes of issues, leading to enhanced product quality and compliance over time.1.How do you document and track CAPA activities to ensure ongoing compliance and improvement?oCAPA activities are documented in a CAPA management system, which includes detailed records of the issue, investigation, actions taken, verification of effectiveness, and any follow-up actions. Regular reviews and audits ensure ongoing compliance and improvement.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

Our Large Consumer Manufacturing Client is seeking a Package Engineer to join their team in Fort Washington, PA. This individual will be expected to be onsite a minimum of 2 days a week. The... More Packaging Engineer is responsible for providing technical support in the area of design, development, testing and production scale-up of new package development while collaborating with research and development, marketing, market research, supply chain, process excellence, and other affiliated departments to identify and address packaging needs. They will be develop, write, gain cross-functional alignment, and route for approval package development documentation that captures the above end-to-end project specific information. Some examples of documentations would include Package Component Specifications, Package Development Assessment and Plan documents, Packaging Line Trial Protocols and Reports, Package Development Reports, etc. They will lead the development and assessment of the following types of information to support package development and life cycle management initiatives, including but not limited to the following activities: design requirements, definition of the scope of change, packaging and equipment solution proposals, prior knowledge and knowledge gap assessments, risk assessments, test plans, and test results analysis and conclusions.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

Here?s a rewritten version with the **first and last sentences kept exactly the same** and the middle aligned to **equipment sustainment and maintenance engineering** rather than performance... More improvement:> **Insight Global is looking for a Equipment Engineer to join a growing team supporting the Advanced Manufacturing Industry.** The equipment engineer is responsible for sustaining production equipment through reliability-focused maintenance, troubleshooting chronic and emergent equipment issues, and supporting preventive and corrective maintenance strategies to ensure consistent uptime and asset health. This role partners closely with maintenance, operations, and controls teams to support PLC-based equipment, review and execute maintenance work orders, and assist with equipment troubleshooting, repairs, and upgrades. Responsibilities include supporting equipment acceptance, documentation, audits, spare parts strategy, and continuous improvement efforts related to equipment availability, safety, and long-term lifecycle support. This role can pay between 94K-118K based on an evaluation of total relevant YOE and education level.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

A Client of Insight Global is seeking an Infrastructure Engineer to join their team in Largo, FL. The Infrastructure Engineer will support the management and maintenance of VMware virtual... More infrastructure, including ESXi hosts, virtual machines, and vCenter, within a secure datacenter environment. They will be responsible for monitoring system performance and availability while troubleshooting complex infrastructure issues involving virtualization, networking, and operating systems. Additional duties & responsibilities include:Install, configure, and integrate servers supporting virtualized infrastructure and enterprise services.Implement and maintain DISA STIG compliance for ESXi, virtual machines, and management platforms.Perform system maintenance, backups, and patching according to established operational procedures (may require off-hours support).Configure and support virtual networking and highly available server clusters within a vSphere environment.Coordinate with facilities, engineering, and security teams regarding datacenter operations such as power and cooling requirements.Document system configurations, changes, and operational procedures in accordance with program standards.Support security compliance efforts, vulnerability remediation, and accreditation activities.Contribute as an entry-level professional team member, applying theoretical knowledge to solve technical problems while working under moderate supervision and collaborating with team members.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

Our client, a global leader in medical technology and healthcare innovation, is seeking a Senior Software Engineer to support the development of a modern analytics platform used by hospitals and... More healthcare providers. This role will focus on full-stack web development, building scalable APIs and user-facing applications that power critical healthcare insights. The engineer will work closely with product owners, quality teams, and other engineers in an Agile environment to deliver new features, improve system performance, and ensure high reliability for a customer-facing platform where uptime and product quality are critical. The position involves developing backend services in .NET Core, building frontend components in Angular (or similar frameworks), contributing to API development, and participating in code reviews and technical design discussions. Engineers will also collaborate with testers and DevOps resources while supporting a cloud-based environment (Azure preferred) and modern CI/CD practices.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 an exceptional engineer to join our Consumables NPI & Sustaining team. In this role, you will help drive the seamless transition of new products from development to manufacturing and... More provide technical stewardship for our on-market consumables portfolio, ensuring product quality and global supply continuity. We collaborate closely with experts across research and development, operations and commercial organizations in support of developing new cutting edge products and resolving mission critical problems that threaten robust product performance. To be successful in this role, individuals must (i). be driven to innovate, and to both find and fix problems, (ii). communicate effectively, (iii). have a strong understanding of engineering fundamentals and (iv). be a team player.Day to Day:1. Support testing needs to develop, qualify, or troubleshoot consumable products and/or processes.2. Execution of experiments following well defined workflows and using existing experimental tools. 3. Communicate results clearly and contribute quality data for making critical process development decisions. 4. Role may include (based on level of experience): 5. Design and validate new experimental tools for the characterization of consumable parts. 6. Plan and execute methodical, efficient experiments to ensure the robustness of consumables used in 10X products. 7. Assist in the identification of root cause and troubleshooting of critical process and product failures.8. Identify opportunities for continuous improvement in 10X consumable products and processes.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 Senior Integration and Test (I&T) Engineer to support to the Operational Test and Training Infrastructure (OTTI) for U.S. Space Force Space Training and Readiness Command... More (STARCOM). This role supports the development of live, virtual, and constructive (LVC) training environments that enable Guardians to achieve and sustain full spectrum operational readiness. The Senior I&T Engineer will take a lead role in ensuring the successful integration, testing, and accreditation of software within government cloud environments. Responsibilities include defining verification strategies, validating system requirements, isolating software and system-level defects, and supporting Continuous Integration and Continuous Test (CI/CD) pipelines. The role also involves designing and executing manual and automated unit and end-to-end tests to ensure reliable, mission-ready system performance. This position requires close collaboration with cybersecurity teams and participation in formal test events with government stakeholders, including occasional travel to customer sites. As a key member of an Agile Scrum team, the Senior I&T Engineer will mentor others in integration and test best practices and contribute directly to mission-critical capability delivery.This role is hybrid in Colorado Springs, CO for an initial 6 month contract duration. While on contract with Insight Global you are offered health, dental, and vision benefits as well as access to contribute to a 401k. This position is looking to pay 70-76/hr while on contract. If interested please apply today!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

Will have primary responsibility for small modification or revision projects.Will assist more experienced engineers in large projects standards creation or process and procedure creation.Will assist... More in the review and revision of material and design standards.Act as the project engineer for assigned projects. Create standards and process or procedures as needed or requested.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

One of our largest national retail clients is looking to bring on a Data Engineer to help them with several ongoing modernization projects. This individual will design, build, and optimize scalable... More data pipelines using Spark, SQL, & will be using Google Cloud data products to process, transform, & analyze large data sets. The projects will consist of development, support, and utilizing AI tools for code changes.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 Automation Engineer to join a growing engineering team for a Heavy Industrial Mining client in Chennai, India. This person would be tasked with designing, programming,... More and testing automated systems that optimize and control large mining equipment. This person would be working with on a cross functional engineering team to deliver custom industrial solutions to global mining operations. This person should have an extensive background working with Programmable Logic Controllers, Distributed Control Systems, and Human Machine Interfaces to integrate into mining processing equipment and other relevant apparatuses. Ideally, this person has project management experience and can manage the engineering process from concept to commissioning.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