4 Capa Methodologies Jobs

Job Description Job title: Product Quality Engineer Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common: and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thatu2019s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. You are a part of The Design Quality Engineering Team is tasked with a dual role as an embedded member of project teams to provide expertise and guidance on the Risk Management process as it relates to our quality management system and product safety, and the role of independent oversight to ensure that Philips designs live above the common level and meet the spirit and the letter of the policies that guide product team for safe inherent design Job Responsibilities: u2022 Guides the implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under general supervision. u2022 Ensures the smooth execution of the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring full compliance with regulatory and quality standards. u2022 Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance. u2022 Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle. u2022 Reviews and constantly evaluates product and system designs, guides the analysis of performance data, and performs root cause analysis to address quality deficiencies and ensure design excellence. u2022 Ensures validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements. u2022 Shares subject matter expertise and suggests proactive methods to strengthen risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle. u2022 Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions. u2022 Suggests efficient utilization of post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary. u2022 Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards. u2022 Applies continuous improvement techniques to enhance quality practices and maintain readiness for quality audits, ensuring adherence to both internal and external standards. Minimum required Education: Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education. Minimum required Experience: Bachelor's degree with minimum 4 years of experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent with Vocational Education. Minimum required Certification: N/A Preferred Education: N/A Preferred Experience: N/A Preferred Certification: Six Sigma Green Belt Preferred Skills: u2022 Design Quality Management u2022 Data Analysis & Interpretation u2022 Design for Quality (DFQ) u2022 Root Cause Analysis (RCA) u2022 CAPA Methodologies u2022 Regulatory Requirements u2022 Privacy, Safety and Security Risk Assessment u2022 Technical Documentation u2022 Continuous Improvement u2022 Product Quality and Reliability u2022 Defect Management u2022 Design Verification Planning u2022 Design Validation Planning u2022 Product Test Design How we work at Philips Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office every week and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. In return, we offer you A meaningful career, with new challenges in our dynamic organization, working in an encouraging multinational and multicultural environment. We are happy to provide you with this opportunity to work with new technologies. You will be surrounded by passionate and committed, colleagues who share your ambition to create outstanding customer experiences. Your work will be ambitious and full of opportunities for growth. Variety and challenge will be part of your daily routines. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Description Job Title: Compliance Learning Data Analyst The Compliance Learning Analyst supports compliance training initiatives by assisting in the collection, organization, and basic analysis of training data. The role helps generate reports and visualizations to inform decision-making and contributes to the maintenance of compliance-related learning systems. This position operates under close supervision and follows established procedures to ensure data accuracy and support compliance efforts across the organization. Job Responsibilities: Assists in gathering and organizing compliance training data for reporting and analysis. Supports the creation of basic dashboards and visualizations using standard tools to highlight training trends and gaps. Collaborates with team members to ensure training data is complete, accurate, and aligned with compliance requirements. Helps maintain learning management systems by performing routine quality checks. Follows established protocols to support compliance-related reporting and documentation. Participates in cross-functional meetings to understand training needs and contribute to data-driven solutions. Applies data analytics techniques under guidance to support compliance initiatives. Supports the maintenance and continuous improvement of compliance training analytics solutions. Minimum required Education: Bacheloru2019s degree in Data Analytics or Business Analytics. Minimum required Experience: Minimum 5-7 years work experience in a regulated industry ( Medtech) Preferred Skills Proficiency with data analytics tools like Excel, Power BI - Mandatory Python, SQL, Qlik Sense, Learning Management Systems (LMS) Quality Management Systems (QMS) Data Analysis & Interpretation Regulatory Compliance Quality & Compliance Learning Management Learning Analytics CAPA Methodologies Dashboard Design & Development Business Intelligence Tools System Performance Monitoring Learning Record Store Management Business Acumen Programming Languages How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. #LI-PHILIN

Job Description Job Title: Sr. Software Design Quality Engineer - Reliability Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics Job Responsibilities: Acting as a subject matter expert for reliability for project teams and business functions. Lead the development and implementation of reliability strategies and frameworks for Philis software systems. Collaborate with development, customer facing functions and quality assurance teams to integrate reliability engineering practices throughout the software lifecycle. Facilitating SMART requirements, designs, plans including design failure mode and effect analysis. Design and evolve PMS monitoring (Software) and alerting solutions to proactively identify and resolve potential issues. Conduct root cause analysis of system failures and implement corrective and preventive measures. Develop and sustain tools and frameworks for automating reliability testing and validation processes. Ensure high system availability by implementing redundancy, failover mechanisms, and service recovery strategies. Mentor and coach other engineers on reliability best practices and foster a culture of continuous improvement. Stay abreast of industry trends and emerging technologies to recommend improvements to existing systems and practices. Lead reliability reviews, audits, and assessments to ensure compliance with set standards and practices. Facilitate risk analysis and management to prioritize and address reliability threats effectively. Participating in audits and regulatory inspections as a design quality SME. Minimum required Education: Bachelor's / Master's Degree in Computer Science, Electronics engineering or equivalent. Minimum required Experience: Minimum 16 years of experience with Bachelor's OR Minimum 15 years of experience with Master's in areas such as Software Quality Engineering or equivalent. Preferred Certification: ISTQB certification Preferred Skills: u2022 Design Quality Management u2022 Product Quality and Reliability u2022 Software Reliability u2022 Data Analysis & Interpretation u2022 Design for Quality (DFQ) u2022 Root Cause Analysis (RCA) u2022 CAPA Methodologies u2022 Regulatory Requirements u2022 Privacy, Safety and Security Risk Assessment u2022 Software Development Life Cycle (SDLC) u2022 Defect Management u2022 Design Verification and Validation Planning u2022 Product Test Design How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our companyu00A0 , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law.u00A0 For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Description One sentence description of role Your role: Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection. Conducts & reviews DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request). Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality. Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers. Facilitates collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation. Focuses that Critical to Quality (CtQ) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process. Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval. Executes supplier improvement and development initiatives on APQP(Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency. Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained. Suppports in end to end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier-caused, and acts as an independent reviewer for Supplier Corrective Action Requests. u00A0 You're the right fit if: (4 x bullets max) 1. Experience- Minimum of 10 years of related engineering experience (medical device or regulated industry preferred and commodities like Sheetmetal and Plastic). 2. Skills- Supplier Quality Management Quality Management Procedures and Methodologies Supplier Evaluation Methodologies Data Analysis & Interpretation DfX Methodology Supply Chain Management (SCM) Quality Specifications CAPA Methodologies Statistical Process Control (SPC) Measurement Systems Analysis (MSA) Process Validation and Verification (PV&V) First Article Inspections Documentation & Reporting Regulatory Requirements Continuous Improvement 3. Education. Any Engineering (Preferred Mechanical Engineering) 4. Anything else- DFSS Black Belt, LEAN Six Sigma or equivalent. Domain - Medical device or regulated industry preferred. Leadership experience to manage stakeholders. u00A0 How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .