QMS Specialist Consultant
QMS Specialist Consultant (Randstad Contingent Worker)
This position will be fully remote and can be home-based from anywhere in the US.
In this role, you will have the opportunity to:
Focused Area - QMS Consultant & Design Control Remediation
Develop and implement systems to ensure software as a medical device (SaMD) and services are designed and produced to meet or exceed customer and regulatory requirements-expectations. Establish the principles of product and service quality evaluation and control for the system.
You will be responsible for:
• Provides quality engineering insight/ guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, post market surveillance in accordance with FDA 21CFR, IEC62304, MDR, MDD, Canada Medical Device Regulations, etc.
• Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Legal Manufacturers, Notified Bodies, existing products in the EU regions, documentation and other aspects of medical device.
• Develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
• Provides effective oversight to the execution of the Quality Plan, Risk Management activities and post market surveillance activities.
• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Have knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
• Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Have experience of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
• Represents QMS/Engineering Change processes and records to regulatory agencies as required
• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
• Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities
• Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
• Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
• Develop inspection and test strategies.
• Reviews and assists in the development of verification and validation protocols and reports and identifies gaps for compliance with internal processes.
• Author validation, verification, and inspection assessments to ensure the defensibility of product test data. Selects appropriate testing sample sizes based on criticality and statistical calculation.
• Participates on teams to ensure robust application of appropriate design and manufacturing controls.
• Supports leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
• Provides ongoing quality engineering support throughout the software product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
To succeed in this role, you should have the following skills and experience:
• Strong working knowledge and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, IEC 62304, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
• Engineering Degree or equivalent experience in medical device industry.
• At least 5 years’ experience in with Medical Devices.
• ASQ certified Quality Engineer is a plus.
• Understand risk analysis philosophies, methodologies, and their applications.
• Have a working understanding of LEAN and six sigma concepts, methodologies and deployment.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
• Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
• Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
• Strong IT Skills
• Ability to travel up to 25%
You will be a part of:
You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around world.
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.