Quality Assurance CAPA Officer
We are looking for a Quality Assurance CAPA officer.
Reporting to the Quality System Manager, the Quality Assurance CAPA officer (QA officer) provides comprehensive management of existing and potential problems resulting from quality assurance concerns, customer complaints, audits, process problems, etc. to assure continuous compliance.
He is responsible to ensure compliance with Quality Management System and regulations that govern activities during product development, validation, release and maintenance activities. At Philips Digital Pathology Solutions the QA CAPA officer cooperates closely with Product Development, Medical Affairs, Regulatory, and Marketing and Sales. Next to the core responsibilities the candidate is expected to help other members of the team with their responsibilities and contribute to the overall success of the business. As a QA group member the specialist should be able to contribute in discussions on all QA topics.
Digital pathology is a rather new field in pathology and is the biggest innovation in pathology which happened for over the last 30 years. Therefore, new methodologies have to be set up in accordance with the regulations. All this makes working in the group both exciting as well as challenging.
The team consists of relative young professionals and industry experts with a wide variety of backgrounds. Humor, drive, dedication and teamwork are at the heart of the group.
Key areas of responsibility:
• Global facilitation of the CAPA process per all relevant procedures.
• Review of Investigation or CAPA deliverables and clearance for Investigation/CAPA owners to proceed to the next CAPA process step.
• Coordinator of the CAPA Review Board.
• Generation of CAPA process metrics.
• CAPA procedures, WI & templates creation in full compliance with all applicable MD regulations, Philips Healthcare and IS Policies and procedures.
• Ensure alignment of CAPA activities, with other BU’s
• Engage, drive and implement QMS harmonization initiatives for CAPA.
• Analyze and report trends for all its products.
• Be the center of knowledge for all the CAPA practices and the Trackwise tool
• Support and present CAPA during internal and external audits successfully.
Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working
• Support New Product Introduction by providing QA technical expertise, assessments, and strategies for problem resolution & prevention
• Serve as Subject Matter Expert for quality system and CAPA control requirements within project teams
- Proactive, creative and flexible attitude
- Practical, hands-on mentality
- Work precisely according to procedures, rules and regulations and able to keep oversight on processes while understanding the needs of stakeholders in order to drive business results and behaviors
- Ability to set priorities, work independently without direct supervision as well as in a team environment
- Conscientious and precise delivery of work even when under pressure
- Open and clear communicator
- Systematically perform activities in a timely and accurate manner
- Quality, results and goal oriented
Education and Work Experience Qualifications:
- Bachelor degree in related field with 2 years relevant QA CAPA experience in a medical device / IVD company.
- Demonstrated expertise in a highly regulated environment. Preferred knowledge of subjects mentioned below but not limited to:
- ISO Standards (i.e., 13485, 14971)
- US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD), IVD Directives (i.e., IVDD) is a plus
- Auditor certification is a plus
- Excellent communication skills
- A drive for results
- Excellent QA/Regulatory Writing Skills in English
- Proficient in Microsoft and other organizational tools
- Being a team player and ability to collaborate effectively
- Able to work in a goal oriented environment
- Structured way of working
We would like to invite professionals and freelancers to contact us.
We will offer a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
The Philips Digital Pathology (PDP) venture started on 1 May 2007. The venture is establishing a worldwide business for total digital pathology solutions encompassing an ultra fast scanner for microscope tissue slides, a pathology viewer/workstation/PACS and several disease specific (mostly for cancer types) computer assisted detection (CAD) solutions. The venture aims at leveraging multiple Philips assets and capabilities (brand, market channel, technology) for establishing the total solution and being the 1st to market to establish a dominant market position. The market launch of the first solutions was in the first half of 2011 in the USA and UK, followed by the rest of Europe and Asia.
Our mission: In a world with increasing challenges for cancer diagnostic procedures and quality of patient care we want to be number one in empowering pathologists with digital pathology solutions so their expertise is supported by the best scanners, IMS, workflow and IAA solutions available. This helps them work more effectively, leading to higher quality diagnosis and as a result better patient care
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
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