CAPA Officer Medical Devices
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
Large Medical Devices production company.
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/she is responsible to ensure compliance with Quality Management System and regulations that govern activities during product development, validation, release and maintenance activities. 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.
- 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, 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
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.