Quality Systems Engineer

Job Summary The Quality Systems Engineer is responsible for ensuring an efficient and compliant Quality Management System (QMS). The role includes analysis, development and revision of QMS processes, performance monitoring, continuous improvement, and ensuring accuracy and compliance with relevant standards. Responsibilities Takes ownership of quality processes, including audits, document control, training, CAPA, and related activities. Analyzes QMS metrics and performance indicators, prepares detailed reports highlighting trends, deviations, and areas for improvement, and presents findings to senior management. Contributes to the development, implementation, and revision of QMS processes, including SOPs, work instructions, and quality manuals, ensuring accuracy, clarity, and standard compliance. Conducts risk assessments, identifies potential risks to regulatory compliance and QMS integrity, and develops robust mitigation strategies. Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems. Applies specialized knowledge to a variety of issues and projects, ensuring effective solutions and innovative approaches to complex challenges. Participates in training sessions to stay up‑to‑date on quality standards and QMS procedures. Cultivates effective relationships with internal and external partners, influencing projects and peer groups by demonstrating comprehensive expertise. Leads cross‑functional problem‑solving sessions to address significant QMS issues, utilizing structured methodologies such as root cause analysis and driving implementation of solutions. Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provides responses to audit findings in collaboration with stakeholders. Qualifications Minimum 5+ years’ experience in FDA‑regulated (ISO 13485) medical device quality operations/manufacturing environments focused on QMS compliance. Experience managing and maintaining training metrics and matrices. Proven experience leading cross‑functional teams and mentoring less experienced engineers. Detailed experience in CAPA processes, including problem identification, root cause analysis/tools, and implementation of solutions to prevent recurrence. Experience with data analysis and understanding of QMS metrics/KPI, preparing detailed trend reports for senior management. Strong relationship‑building skills with supervisors, peer groups, stakeholders, and suppliers. Bachelor’s degree in Quality, Engineering, or a related discipline (required). ASQ‑CQE or ISO Lead Auditor certification desirable. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. All qualified applicants are eligible for consideration. #J-18808-Ljbffr