{"schemaVersion":"jobsearcher.job.v1","id":"9a3a258e99252ce76d7bb652","url":"https://jobsearcher.com/jobs/9a3a258e99252ce76d7bb652","canonicalUrl":"https://jobsearcher.com/jobs/9a3a258e99252ce76d7bb652","title":"Quality Systems Engineer","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\r\nQuality Systems Coordinator Full Time Stevens Point, WI, US\r\n4 days ago Requisition ID: 1624\r\nJob Summary The Quality Systems Coordinator is responsible for supporting the administration and maintenance of the Quality Management System (QMS) across Quality Assurance and Regulatory Affairs functions. This role coordinates document control activities, training records, complaint documentation, audit support, quality system records, and quality data reporting. The position helps ensure quality system activities remain organized, timely, and compliant with FDA, ISO 13485, and other applicable regulatory requirements while enabling Quality and Regulatory personnel to focus on compliance, risk management, investigations, and continuous improvement activities.\r\nJob Responsibilities Maintain controlled quality documents, records, forms, SOPs, work instructions, and templates within document management systems, ensuring accuracy, compliance, and accessibility.\r\nCoordinate document revisions, formatting, routing, review, approval, distribution, and document control activities.\r\nReview documents for formatting, completeness, consistency, and compliance with document control requirements.\r\nSupport internal and external audits by scheduling activities, collecting records, preparing documentation, and tracking audit findings, and following up on corrective actions and quality system commitments.\r\nMaintain employee training records and matrices while supporting onboarding and training documentation activities.\r\nEnter, organize, review, and maintain quality system records within electronic databases and enterprise software systems.\r\nMaintain Quality Management System records, logs, and performance metrics, as well as, organized electronic and physical filing systems.\r\nSupport complaint handling activities through data entry, file maintenance, documentation control, and record organization.\r\nAssist quality personnel with investigations by gathering information and preparing supporting documentation.\r\nCompile quality metrics, reports, and trending data for management review and continuous improvement activities.\r\nSupport supplier quality and compliance activities as assigned.\r\nPerform routine data analysis and trending using spreadsheets and reporting tools.\r\nParticipate in continuous improvement projects and quality system improvement initiatives.\r\nEnsure adherence to ISO 13485, FDA Quality System Regulation (QMSR), and other applicable regulatory requirements.\r\nMaintain a safe, neat and orderly work environment.\r\nEnsure and follow safety requirements and standards.\r\nAdhere to Company's Quality System requirements.\r\nPerforms all duties in a manner that follows, demonstrates, and promotes Company's values.\r\nReport to work as scheduled, on time, and able to work the entire work schedule.\r\nPerform additional duties as assigned.\r\nKnowledge, Skills, and Ability Strong attention to detail and organizational skills.\r\nAbility to manage multiple tasks, priorities, and deadlines.\r\nEffective written and verbal communication skills.\r\nProficiency using Microsoft Office applications, including Word, Excel, Outlook, and Teams.\r\nAbility to learn and utilize document control and quality management software systems.\r\nAbility to maintain confidential and sensitive information appropriately.\r\nAbility to work effectively both independently and within a team environment.\r\nBasic analytical and problem-solving skills.\r\nAbility to compile, organize, and report quality system data.\r\nAbility to follow procedures and maintain accurate records.\r\nAbility to adapt to changing business needs and priorities.\r\nDemonstrated professionalism, accountability, and reliability.\r\nAbility to observe and identify details.\r\nAbility to work extended hours as scheduled, including weekends.\r\nPhysical Demands Frequent sitting, wrist manipulation, walking, and standing.\r\nFrequent sedentary work with lifting and carrying up to 10 pounds.\r\nOccasional medium work with lifting and carrying up to 40 pounds.\r\nManual dexterity to type and operate office equipment occasionally.\r\nMust be able to complete all physical requirements to perform essential functions.\r\nQualifications Education Equivalent combination of education and experience may be considered.\r\nExperience Required: 1-3 years of administrative, document control, records management, data entry, or manufacturing support experience.\r\nIntermediate proficiency with Microsoft Office applications including Word, Excel, Outlook, and Teams.\r\nStrong attention to detail and organizational skills.\r\nPreferred: Experience working in a manufacturing environment.\r\nExperience with document control systems, training records, or quality records.\r\nExperience in a regulated industry (medical device, aerospace, automotive, pharmaceutical, etc.).\r\nStandard working conditions include a temperature-controlled office and manufacturing environment.\r\nThis position does not now or in the future provide immigration sponsorship.\r\nThis position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.\r\nThis job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.\r\nKi Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.\r\nJ-18808-Ljbffr","company":"Ki Mobility","rawCompany":"ki mobility","city":"Stevens Point","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-08-09T00:49:41.731Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"312111","title":"Soft Drink Manufacturing","slug":"soft-drink-manufacturing"},{"code":"623110","title":"Nursing Care Facilities (Skilled Nursing Facilities)","slug":"nursing-care-facilities-skilled-nursing-facilities"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Systems Engineer","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\r\nQuality Systems Coordinator Full Time Stevens Point, WI, US\r\n4 days ago Requisition ID: 1624\r\nJob Summary The Quality Systems Coordinator is responsible for supporting the administration and maintenance of the Quality Management System (QMS) across Quality Assurance and Regulatory Affairs functions. This role coordinates document control activities, training records, complaint documentation, audit support, quality system records, and quality data reporting. The position helps ensure quality system activities remain organized, timely, and compliant with FDA, ISO 13485, and other applicable regulatory requirements while enabling Quality and Regulatory personnel to focus on compliance, risk management, investigations, and continuous improvement activities.\r\nJob Responsibilities Maintain controlled quality documents, records, forms, SOPs, work instructions, and templates within document management systems, ensuring accuracy, compliance, and accessibility.\r\nCoordinate document revisions, formatting, routing, review, approval, distribution, and document control activities.\r\nReview documents for formatting, completeness, consistency, and compliance with document control requirements.\r\nSupport internal and external audits by scheduling activities, collecting records, preparing documentation, and tracking audit findings, and following up on corrective actions and quality system commitments.\r\nMaintain employee training records and matrices while supporting onboarding and training documentation activities.\r\nEnter, organize, review, and maintain quality system records within electronic databases and enterprise software systems.\r\nMaintain Quality Management System records, logs, and performance metrics, as well as, organized electronic and physical filing systems.\r\nSupport complaint handling activities through data entry, file maintenance, documentation control, and record organization.\r\nAssist quality personnel with investigations by gathering information and preparing supporting documentation.\r\nCompile quality metrics, reports, and trending data for management review and continuous improvement activities.\r\nSupport supplier quality and compliance activities as assigned.\r\nPerform routine data analysis and trending using spreadsheets and reporting tools.\r\nParticipate in continuous improvement projects and quality system improvement initiatives.\r\nEnsure adherence to ISO 13485, FDA Quality System Regulation (QMSR), and other applicable regulatory requirements.\r\nMaintain a safe, neat and orderly work environment.\r\nEnsure and follow safety requirements and standards.\r\nAdhere to Company's Quality System requirements.\r\nPerforms all duties in a manner that follows, demonstrates, and promotes Company's values.\r\nReport to work as scheduled, on time, and able to work the entire work schedule.\r\nPerform additional duties as assigned.\r\nKnowledge, Skills, and Ability Strong attention to detail and organizational skills.\r\nAbility to manage multiple tasks, priorities, and deadlines.\r\nEffective written and verbal communication skills.\r\nProficiency using Microsoft Office applications, including Word, Excel, Outlook, and Teams.\r\nAbility to learn and utilize document control and quality management software systems.\r\nAbility to maintain confidential and sensitive information appropriately.\r\nAbility to work effectively both independently and within a team environment.\r\nBasic analytical and problem-solving skills.\r\nAbility to compile, organize, and report quality system data.\r\nAbility to follow procedures and maintain accurate records.\r\nAbility to adapt to changing business needs and priorities.\r\nDemonstrated professionalism, accountability, and reliability.\r\nAbility to observe and identify details.\r\nAbility to work extended hours as scheduled, including weekends.\r\nPhysical Demands Frequent sitting, wrist manipulation, walking, and standing.\r\nFrequent sedentary work with lifting and carrying up to 10 pounds.\r\nOccasional medium work with lifting and carrying up to 40 pounds.\r\nManual dexterity to type and operate office equipment occasionally.\r\nMust be able to complete all physical requirements to perform essential functions.\r\nQualifications Education Equivalent combination of education and experience may be considered.\r\nExperience Required: 1-3 years of administrative, document control, records management, data entry, or manufacturing support experience.\r\nIntermediate proficiency with Microsoft Office applications including Word, Excel, Outlook, and Teams.\r\nStrong attention to detail and organizational skills.\r\nPreferred: Experience working in a manufacturing environment.\r\nExperience with document control systems, training records, or quality records.\r\nExperience in a regulated industry (medical device, aerospace, automotive, pharmaceutical, etc.).\r\nStandard working conditions include a temperature-controlled office and manufacturing environment.\r\nThis position does not now or in the future provide immigration sponsorship.\r\nThis position is subject to a background check. A prior conviction or pending charge will not automatically disqualify you from consideration. In accordance with the Fair Credit Reporting Act and Wisconsin Fair Employment Act, criminal histories will only be evaluated if the circumstances of the offense substantially relate to the duties of this position.\r\nThis job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodation.\r\nKi Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.\r\nJ-18808-Ljbffr","datePosted":"2026-08-09T00:49:41.731Z","dateModified":"2026-08-09T00:49:41.731Z","hiringOrganization":{"@type":"Organization","name":"Ki Mobility","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Stevens Point","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9a3a258e99252ce76d7bb652"},"url":"https://jobsearcher.com/jobs/9a3a258e99252ce76d7bb652"}}