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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality Systems Engineer - **Company:** Koninklijke Philips N V - **Location:** Bedford, VA, United States - **Experience:** Expert - **Salary:** $102,480.0 - $163,968.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Systems Engineering, Document Management Systems, Performance Monitor - **Published:** September 23, 2026 - **Apply:** https://www.careerbuilder.com/job-details/senior-quality-systems-engineer-bedford-ma--d2ae88aa-bb59-4a55-a929-ef2b49d169a2 ## About the Role * You have a minimum of 5+ years' experience in FDA/ISO 13485 medical device quality operations/manufacturing environments, with a focus on QMS compliance, documenting QMS changes, gap assessments, Audits, Document Control, Training, CAPA's, etc. * You have experience managing/maintaining training metrics/matrix. * You have proven experience leading cross-functional teams and the ability to mentor less experienced engineers. * You have detailed experience/knowledge in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence and drive continuous improvement. * You're experienced in Data analysis, understanding QMS metrics/key performance indicators (KPI), preparing detailed reports that highlight trends, deviations, areas for improvement, and presenting findings to senior management. * You're able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc. * You have a minimum of a Bachelor's Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE, ISO Lead Auditor certifications-desired. * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office-based role., American Society for Quality (ASQ), Analysis Skills, Auditing, Best Practices, Certified Quality Engineer (CQE), Compensation and Benefits, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Document Control, Documentation, Environmental Work, External Audit, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), Identify Issues, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Mentoring, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Improvement, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Reimbursement, Reporting Skills, Risk Analysis, Root Cause Analysis, Standard Operating Procedures (SOP), Stock Purchase Plans, Strategic Planning, Systems Engineering, Team Lead/Manager, Trend Analysis, Willing to Travel ## Description The Senior Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. Your role: * Takes ownership of Quality processes including-Audits, Document Control, Training, CAPA etc. ensuring that QMS is efficient and meets the regulatory requirements. * Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management. * Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards. * Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact. * Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence. * Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges. * Participate in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices. * Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization. * Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions. * Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders. ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Automate everything via NodeJS and Puppeteer](https://www.wearedevelopers.com/videos/322-automate-everything-via-nodejs-and-puppeteer) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) ## Related Articles - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Software Engineer Salary London](https://www.wearedevelopers.com/magazine/252-software-engineer-salary-london)