Job Search Results for medical device regulations

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 FDAs 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

A large medical device company in Irvine, CA is looking for a HYBRID Clinical Research Specialist. This candidate will play a crucial role in supporting a 10 year post market clinical trial for... More breast implants. Their key responsibilities will include monitoring clinical studies, data verification, regulatory compliance, study documentation, site visits and coordination, and developing written travel reports.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 Design Quote Specialist for one of our Medical Device clients for a direct hire opportunity. This person can be located in our Versailles, Ohio or Kansas City, Kansas... More locations and would be expected to be onsite 4x/week. They will be responsible for creating designs and quotes for the companys Animal Health clients by harmonizing the clinical space, workflow, and technology & working closely with customers, distributors, and the companys salesforce to create designs, drawings, specifications, and quotes ESSENTIAL/PRIMARY DUTIES: Creates spaces, designs, and quotes customized for customer needsProvides professional customer interface with customers, architects, dealers, and salesforceDevelops project specifications and pricing, manages changes and revisions, and assures quotes are ready to orderDesigns validation against construction, architectural and design plans, adhering to building codes and ADA requirementsManages work of all sizes, single rooms, facilities, or multi-floor hospitalsLeads/conducts live design sessions with architects, designers, executives, and decision-makersEducates, coaches, and consults with architects, facility planners, and sales teamsManages multiple requests, tasks, and deadlinesUtilizes 3D software in an accurate and timely mannerEnsures Midmarks compliance with ISO9002 procedures and guidelinesWe 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 highly motivated and experienced Team Leader to oversee a group of 10 technicians as they perform asset tagging of medical equipment across each site. The ideal candidate will have... More previous experience working in a medical setting and possess the ability to coach the team on appropriate behavior and advise them on the identification of different device types. Key Responsibilities: Lead and manage a team of 10 asset tagging technicians as they tag and scan medical equipment across multiple hospital locations. Provide guidance and coaching to the team on professional behavior and best practices when operating in a medical environment. Advise technicians on the identification of various medical devices. Ensure accurate and efficient asset tagging processes are followed. Partner with our service delivery manager, travel coordinators and customer to agree team schedules. Maintain clear communication with hospital staff, Insight Global, and customer stakeholders Monitor and report on the progress of asset tagging activities. Address any issues or challenges that arise during the project, in conjunction with our remote service delivery manager.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 a Manufacturing Operator to join their team in the SE Houston, TX area. This person will assemble, test, and inspect medical devices to ensure they comply with... More company procedures. They will ensure traceability compliance by maintaining accurate production documentation, maintaining accurate material inventory, and identifying possible process or product improvements. This person will be responsible for ensuring all production activities are in full compliance with all regulatory, Quality System, and GMP requirements.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 medical device manufacturing client in Bothell, WA is looking to hire an assembler to add to their team. This individual will be responsible for the production assembly of medical devices working... More specifically to construct compact ultrasound machines. They should have knowledge/ experience of working in a highly regulated environment. They should be able to follow written and verbal instructions. Lean Manufacturing experience is a plus. Operations may require an individual to use safety equipment including glasses, gloves, hearing protection, steel toed boots. They should feel comfortable using mechanical and electrical tools, power tools, torque wrenches, hand tools and compressed gas. This person will be assembling small parts and the role will be highly dexterous in nature. The ideal candidate is highly flexible and willing to work overtime as needed, learn multiple disciplines in the assembly line, and has a go getter attitude/ ready to step in and get the job done.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 large life sciences client of ours is looking for a senior quality engineer to join their team for a 6-month project (with possibility of extension). This individual will be working on a large New... More Product Development project. They will develop and maintain risk management documentation to support product development, identify potential device risks, assess their impact, and develop mitigation strategies, and ensure compliance with industry standards and regulatory requirements.They will also gather and document design inputs and outputs, create and maintain design validation files, and ensure all design requirements are measurable and validated through appropriate testing. This role entails developing and implementing studies to test product performance and reliability, creating sampling plans for studies and analyzing data to ensure product specifications are met. This individual will write detailed protocols for product studies, improve protocols based on feedback and testing results, and document and report findings and improvements after testing. They will Implement production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics), perform or guide Measurement Systems Analysis (MSA) and basic reliability testing/analysis, and support the qualification of components and/or processes at external suppliers. This is hybrid 3x a week in Raritan, NJ.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 is looking for a Proposal Specialist/Business Representative to join their lab located in Midland, MI. This individual will join a team that writes proposals for chemistry focused studies... More for the following disciplines: consumer products, medical device, pharmaceuticals, specialty chemistry and bioanalytical. A request will come through the website/email and this person will meet with the client to gather specific specs that they are looking to uncover in the study. Then, you will either connect with the lab analyst to discuss how they would conduct the study or use your prior chemistry knowledge to write a proposal for how the study would be conducted. You will also include pricing in the proposal. Once the client accepts the proposal, the lab will begin working on the study. When the lab delivers the study to the client, you will be paid commission for the deal. You could work on anywhere from three to twelve proposals in a day depending on your experience level and the complexity of the proposal. 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 SME in Corrective and Preventative Actions (CAPA) to analyze and advise involved teams throughout the various end-to-end CAPA investigation processes. The responsibilities... More of this person will be as follows:- Complete product and process CAPA review tasks such as identifying issue descriptions, reviewing data, facilitating root cause analysis, advising on solutions, implementing solutions, and effective monitoring of the product post-CAPA- Initiative CAPA investigations and advise on solutions to cross-functional teams- Manage CAPA activities across all cross-function teams, including scheduling CAPA team meetings, ensuring the deliverable timeline will be met, ensuring effective monitoring post analysis, represent the CAPAs during audits and Review Board meetings, and mentoring the team throughout the analysis process- Confidently work in a high pressure environment while delivering on multiple projects with urgencyWe 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 mid-sized manufacturing company specialized in plastics manufacturing for medical devices is seeking a strong Business Analyst with a strong background in reporting and financial consolidation to... More join to join their team. The ideal candidate will have extensive experience with Cognos (Controller, TM1, BI) and Power BI, and will be responsible for managing our enterprise reporting platform. This role requires a business-focused individual with excellent communication and influential skills, who can understand and translate business requirements into actionable insights. The ideal candidate should have at least 5 years of working experience as a Business Analyst in an enterprise organization, have strong requirements gathering and translating skills, excellent communication skills, and should have proven experience interfacing with various levels of business and technical teams. This is an immediate, 6 month contract to hire need, and will require 3 days a week onsite in Wilmington, DE. Responsibilities: Lead business process reporting initiatives within the healthcare sector.Collaborate with business stakeholders to understand and translate requirements.Develop and maintain financial and accounting reports using Cognos (Controller, TM1, BI) and Power BI.Write and optimize SQL scripts for data extraction and reporting.Manage the transition from Cognos BI to Power BI.Ensure accurate and timely financial consolidation and reporting.Create structure, timelines, and interface with the business to ensure project success.Provide 1-2 weeks of handover support before the current employee leaves.Work with Oracle databases and Cognos for financial reporting.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