CAPA Engineer at Philips

Mainz, Rhineland-Palatinate, Germany -

Full Time

Start Date

Immediate

Expiry Date

14 Feb, 26

Salary

0.0

Posted On

16 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Project Management, Troubleshooting, KPI Monitoring and Reporting, Data Analysis & Interpretation, Process Improvements, Technical Writing, Regulatory Requirements, User Training & Support, Training Content Development

Industry

Hospitals and Health Care

Description

Job Title CAPA Engineer Job Description As a QMS Specialist - CAPA, you’ll take ownership of key quality processes to ensure our CAPAs runs smoothly, efficiently, and in full compliance with industry standards. Working with a high level of independence, you’ll analyze corrective and preventive actions plans & investigations, prepare insightful reports, and present recommendations directly to senior management. You’ll play a hands-on role in shaping and refining QMS CAPAs, driving continuous improvement, and finding smart solutions to complex challenges. Your role: • Takes ownership of basic processes in the assigned area/areas (Audits, CAPA) to ensure that QMS is efficient and meets the QMS/CAPA and regulatory requirements. • Analyzes CAPA metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management. • Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance. • 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. • 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. You're the right fit if: •Bachelor's / master’s degree in a relevant field •Minimum 5 years of experience in areas such as CAPA, Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive. • Fluency in English. •Fluency in German is an advantage. Preferred Skills: • Quality Management Systems (QMS) • Project Management • Troubleshooting • KPI Monitoring and Reporting • Data Analysis & Interpretation • Process Improvements • Technical Writing • Regulatory Requirements • User Training & Support • Training Content Development • Regulatory Requirements *The position isn't open for relocation 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 company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. 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. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re 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 here. #LI-EU #LI-OFFICE At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Responsibilities

The CAPA Engineer will take ownership of key quality processes to ensure CAPAs run smoothly and in compliance with industry standards. They will analyze CAPA metrics, prepare reports, and present findings to senior management while driving continuous improvement initiatives.