Job Search Results for Biomedical engineering

Job Title: Quality EngineerDepartment: QualityClassification: Contract (6-months)Position SummaryThe Quality Engineer will support and maintain the Quality Management System (QMS) in a regulated... More medical device environment. This role is responsible for activities including document control, regulatory compliance, sterilization coordination, CAPA, risk management, and audit support related to the design, development, manufacture, and distribution of medical devices.Key Responsibilities? Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable international medical device regulations (including MDR)? Support and maintain compliance with QSR and GMP requirements across assigned areas? Manage the Corrective and Preventive Action (CAPA) process from investigation through effectiveness checks? Maintain Design History Files (DHF), Technical Files, and supporting documentation for internal and external audits? Coordinate and support sterilization qualifications and ongoing maintenance activities? Review and approve validation protocols and reports (IQ/OQ/PQ)? Utilize quality tools such as FMEA, Control Plans, and Process Flow Diagrams? Support risk management activities throughout the product lifecycle? Develop, execute, and document department and company-wide training? Organize and prioritize multiple tasks to meet project timelines and business needsPrepare and review technical documentation with a high level of accuracy and clarityWe 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 looking for a QC Analytical Investigator to sit on-site at a brand new facility in the beautiful Seaport district of Boston supporting one of our top pharmaceutical clients. This is... More a first shift role, on-site Monday through Friday. This position will be supporting the growing technical services team in their risk assessment efforts. This role will be responsible for conducting RCA, assessing impacts, and developing CAPAs to ensure efficient and effective processes across the cell and gene therapy organization. A strong candidate for this role will have a strong background in QC Analytical risk assessments, in GMP environment, leading, writing and reviewing deviations and investigations. Th This person will need to be comfortable managing several projects simultaneously with various stakeholders, maintaining a project management mind-set. Additionally, they should be comfortable working independently and confidently managing decisions on their own. This is an amazing opportunity for a mid-level professional to get their foot in the door at a fast-paced and high growth company and take the next step in their career!We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. 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

The Service Coordinator is responsible for assigning, monitoring and tracking helpdesk and team break fix and service request tickets and coordinates team assignments via a variety of tools. They... More will enter tickets directly into tracking tool. Researches missing information and updates ticket with same. Schedules technician site visit. Responsible for all follows-up with customers to ascertain satisfaction with services. Collects data and prepares reports on call volumes and other key metrics..Job Duties: Answer telephones Assign work orders to technicians through telephone requests and web requests Receive shipments and distribute received merchandise to technicians Work within the TMS software program to create work orders, enter assets, and make any changes necessary relevant to hospital equipment Provide support to department manager, technicians, lead CE coordinator, and PM Manager Generate typed PM stickers for technicians Ship equipment through UPS software, or utilize any other carrier if necessary Send out small tools and equipment to vendors for repair Request purchase orders from purchasing Manage medical scopes Any ad hoc assignments givenWe 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 QA to join one of our largest pharmaceutical clients 5x/week onsite in Rensselaer, NY. This individual will be joining the Cleanroom team within the Facilities Engineering... More space assisting in lifecycle of reports being processed by the QA team. They will be responsible for managing reports from vendors, executing report reviews, adjusting QA comments, and pushing through to the next step in the report lifecycle. They will be expected to perform a high-level review through QA, identify any Gx issues, and ensuring acceptance criteria is accurate. This will be a mainly individual contributor but will be expected to work cross functionally with QA for oversight from the team when needed.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 Senior QA Specialist in Supplier Quality Assurance who will play a critical role in managing and improving supplier and contract manufacturer (CMO) relationships. This person will... More lead efforts to qualify, monitor, and reassess suppliers?especially during design transfers and new product introductions. This includes conducting audits, managing non-conformances, and ensuring compliance with FDA, ISO 13485, and EU IVDR standards. You?ll collaborate closely with R&D, Supply Chain, and external partners to define supplier selection criteria, establish quality agreements, and oversee technical transfers. This is a full-time hybrid role with an anticipated onsite presence of three days per week and approximately 30% travel, primarily domestic with occasional international visits.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