Position OverviewWe are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, c and promote continuous improvement initiatives throughout the organization.Key ResponsibilitiesDesign and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.Participate support the implementation of corrective and preventive actions to address identified issues.Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departmentsQualificationsBachelor’s degree lity Management, or a related field.At least three years of experience working with quality systems in a regulated industry.Comprehensive understanding of ISO, FDA, or other applicable standards.Strong analytical, problem-solving, and communication skills.Certification h as Six Sigma or CQE, is preferred.Required SkillsPreferred Skills:Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training PeopleAdditional Description For Pay TransparencySubject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.BenefitsSubject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
about 1 month ago