{"schemaVersion":"jobsearcher.job.v1","id":"b4e8e3c3bd78ea75b053fea0","url":"https://jobsearcher.com/jobs/b4e8e3c3bd78ea75b053fea0","canonicalUrl":"https://jobsearcher.com/jobs/b4e8e3c3bd78ea75b053fea0","title":"Sr. Manager Quality Engineer","description":"SUMMARY:\nManage Supplier Quality Engineering group and Contract Manufacturing Quality in support of the manufacturing, development, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA, and other governmental regulations within Supplier Management processes and group.\n\nManage and direct the collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.\nManage all employee related activities, including day-to-day resourcing, hiring, mentoring and on-going development of the staff.\nRecommends changes to policies and establishes procedures that affect section or multiple disciplines.\nPartner with Procurement, R&D, Operations, Supply Chain and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.\nMonitor the analysis of supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.\nMonitor and manage SCARs resolution and implementation of each SCAR, managing the SCAR age metric.\nManaging supplier Audits/requalification process.\nManaging the Incoming Inspection Team, process, oversee incoming inspection acceptance activities, offering direction to specify and develop component acceptance criteria/test procedures for purchased subassemblies and components.\nSpearhead and supplier related non-conformances, including leading/participating in investigations.\nAnalyse product/components failures, metrics and deep failure analysis to offer advice in project management activities that address said failures and metrics improvement.\nDevelop, implement and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for quality process reviews identifying issues/performance, or component design improvement activities.\nHelp in project management activities for a series of product, compliance and quality projects\nEnsure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.\nProvide quality metric data to various functional groups within the organization.\nActively promote and support the company’s management review process.\nConduct Supplier qualification audits for new supplier (when is required) by planning, conducting, reporting, and follow-up on supplier quality system audits.\nDrive and execute supplier quality agreements by working with different department within ICI and the suppliers.\nOversee the component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.\nApply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects.\nResponsible for presenting supplier-related issues or opportunities to next management level.\nManage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff.\nManage, Train and mentor engineers, IQC Technicians and other project team members on best practices in quality engineering and regulatory compliance to external standards.\nEDUCATION/EXPERIENCE:\nBS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Lead development and validation of test methods to comply with recognized standards\n2+ years of supervisory experience strongly preferred\nExperience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.)\nMust have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971), and good manufacturing practices.\nExcellent communications skills (both written and verbal)\nMust be able to write clear, concise, and well thought out technical documentation.\nAbility to communicate effectively, both orally and in writing, with all organizational levels\nStrong attention to detail and ability to function in a fast-paced dynamic environment.\nLead auditor certification a plus\nAt Imperative Care, employees share in our collective success through a comprehensive rewards package that includes stock options, bonus opportunities, competitive salaries, a 401(k) plan, health benefits, generous paid time off, and a parental leave program.\n\nSalary Range - 190,000-210,000\nThe salary range provided is a general guideline. When determining an offer, Imperative Care considers several factors, including the scope and responsibilities of the position, the candidate’s experience, education and training, key skills, internal equity, location, market conditions, and business needs.\nJoin us and help shape the future of stroke care.\nThe use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.\nImperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.\nKHoHDO6wK4","company":"Imperative Care","rawCompany":"imperative care","city":"Campbell","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-07-27T11:30:34.579Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Manager Quality Engineer","description":"SUMMARY:\nManage Supplier Quality Engineering group and Contract Manufacturing Quality in support of the manufacturing, development, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA, and other governmental regulations within Supplier Management processes and group.\n\nManage and direct the collaboration with suppliers/CMs/OEMs and business partners to ensure robust materials, products, processes, and systems.\nManage all employee related activities, including day-to-day resourcing, hiring, mentoring and on-going development of the staff.\nRecommends changes to policies and establishes procedures that affect section or multiple disciplines.\nPartner with Procurement, R&D, Operations, Supply Chain and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.\nMonitor the analysis of supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.\nMonitor and manage SCARs resolution and implementation of each SCAR, managing the SCAR age metric.\nManaging supplier Audits/requalification process.\nManaging the Incoming Inspection Team, process, oversee incoming inspection acceptance activities, offering direction to specify and develop component acceptance criteria/test procedures for purchased subassemblies and components.\nSpearhead and supplier related non-conformances, including leading/participating in investigations.\nAnalyse product/components failures, metrics and deep failure analysis to offer advice in project management activities that address said failures and metrics improvement.\nDevelop, implement and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for quality process reviews identifying issues/performance, or component design improvement activities.\nHelp in project management activities for a series of product, compliance and quality projects\nEnsure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.\nProvide quality metric data to various functional groups within the organization.\nActively promote and support the company’s management review process.\nConduct Supplier qualification audits for new supplier (when is required) by planning, conducting, reporting, and follow-up on supplier quality system audits.\nDrive and execute supplier quality agreements by working with different department within ICI and the suppliers.\nOversee the component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.\nApply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for supplier quality management (SQM) projects.\nResponsible for presenting supplier-related issues or opportunities to next management level.\nManage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff.\nManage, Train and mentor engineers, IQC Technicians and other project team members on best practices in quality engineering and regulatory compliance to external standards.\nEDUCATION/EXPERIENCE:\nBS in Engineering or related discipline and 8+ years of supplier quality experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Lead development and validation of test methods to comply with recognized standards\n2+ years of supervisory experience strongly preferred\nExperience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.)\nMust have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485), risk management standards (ISO 14971), and good manufacturing practices.\nExcellent communications skills (both written and verbal)\nMust be able to write clear, concise, and well thought out technical documentation.\nAbility to communicate effectively, both orally and in writing, with all organizational levels\nStrong attention to detail and ability to function in a fast-paced dynamic environment.\nLead auditor certification a plus\nAt Imperative Care, employees share in our collective success through a comprehensive rewards package that includes stock options, bonus opportunities, competitive salaries, a 401(k) plan, health benefits, generous paid time off, and a parental leave program.\n\nSalary Range - 190,000-210,000\nThe salary range provided is a general guideline. When determining an offer, Imperative Care considers several factors, including the scope and responsibilities of the position, the candidate’s experience, education and training, key skills, internal equity, location, market conditions, and business needs.\nJoin us and help shape the future of stroke care.\nThe use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.\nImperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.\nKHoHDO6wK4","datePosted":"2026-07-27T11:30:34.579Z","dateModified":"2026-07-27T11:30:34.579Z","hiringOrganization":{"@type":"Organization","name":"Imperative Care","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Campbell","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b4e8e3c3bd78ea75b053fea0"},"url":"https://jobsearcher.com/jobs/b4e8e3c3bd78ea75b053fea0"}}