Kristina Kjær Email & Phone Number

Denmark

Hedehusene, Region Hovedstaden, Danmark

As a dedicated QMS Manager, I drive the development, implementation, and continuous improvement of our Quality Management System (QMS), ensuring full compliance with ISO 13485, MDD, MDR, and FDA standards. My strategic and operational responsibilities include:- Spearheading the development, implementation, and maintenance of the QMS to align with industry best practices and regulatory requirements. This includes managing projects related to the development, updates, and implementation of QMS to ensure they meet organizational goals and regulatory standards.- Optimizing efficiency and effectiveness through targeted process improvements and integrating lean management principles to create a culture of continuous improvement.- Overseeing document management, including the creation, administration, and updating of SOPs and other essential QMS documents to maintain accuracy and accessibility.- Training staff on quality management principles to ensure compliance with roles and responsibilities and enhancing team performance.- Leading and participating in internal and external audits to ensure adherence to QMS and GMP standards.- Developing and managing processes for handling NC/CAPA, ensuring timely and effective resolution of deviations.- Providing quality support for the Change Control process, ensuring a structured and efficient approach to change management.Reviewing and updating procedures, instructions, templates, and lists, while managing documentation related to the ESD room.My extensive experience in Quality Management Systems has equipped me with a deep understanding of the critical role quality management plays in regulatory compliance and operational excellence. I am committed to leveraging my expertise to contribute to SPT Vilecon's success, delivering exceptional results, and ensuring the highest level of customer satisfaction.

Hedehusene, Central Denmark Region, Denmark

Advising and Information: Provided expert advice on occupational health and safety. Communicated safety protocols clearly to management and employees.Participation in Safety Committee: Actively contributed to committee meetings and decisions. Collaborated on strategies to enhance workplace safety.Risk Assessment and Inspection: Conducted risk assessments and inspections. Reported risks and ensured corrective measures were implemented.Handling Complaints: Investigated and resolved health and safety-related complaints. Managed conflicts and improved safety solutions.Follow-up and Documentation: Monitored safety improvements and maintained documentation. Reported progress and issues to management.Promoting Safe Work Culture: Fostered a safety-focused culture. Encouraged open communication and supported health-promoting initiatives.

2640 Hedehusene

My daily responsibilities included:- Developing, maintaining, and reviewing QMS documentation: Keeping QMS documents accurate and compliant with regulations. This involves creating, revising, and reviewing documents regularly.- Managing product quality and optimization: Overseeing product quality through testing and analysis. Implementing strategies for quality enhancement and continuous production improvements to reduce defects.- Handling deviations, corrective, and preventive actions: Investigating and addressing deviations from quality standards. Implementing corrective and preventive measures, and tracking their effectiveness.- Ensuring GMP compliance: Monitoring and enforcing Good Manufacturing Practice (GMP) standards. Conducting inspections, audits, and training to maintain GMP compliance.- Supporting Change Control: Managing change control processes, ensuring changes to products or processes are properly evaluated, documented, and implemented smoothly.- Conducting internal audits according to ISO 13485: Planning, executing, and documenting internal audits to assess compliance with ISO 13485 for medical devices, and recommending improvements.- Collaborating with cross-functional teams: Working with departments like R&D, manufacturing, and regulatory affairs to improve quality processes and resolve issues.- Training and mentoring staff: Guiding and training team members on quality standards and best practices to ensure compliance and foster a quality-focused culture.

Volunteer at Intact Denmark, a patient association, where I contribute by handling government grant applications and various ad hoc tasks. I am dedicated to supporting patients and their families by ensuring resources and educational tools that make a difference in their daily lives.

Lejre, Sjælland, Danmark

- Developed, maintained, and modified project documentation for change and artwork & labeling projects, ensuring accuracy and regulatory compliance.- Managed the scrum board and scrum tasks, resulting in effective project management and timely task delivery.- Ensured the availability of necessary documentation to ensure projects complied with internal procedures and standards.- Fostered collaboration and knowledge sharing within projects and the change portfolio, enhancing team productivity and communication.- Acted as DHF Coordinator, coordinating design history files and ensuring proper documentation of design control.- Reviewed non-conformance (NC) reports, ensuring effective follow-up and implementation of corrective actions.- Handled purchasing specifications for both new and updated projects, ensuring accuracy in requirements and delivery.- Processed purchase orders in SAP, ensuring accurate registration and follow-up of all orders.- Served as a superuser of QMS systems (Lotus Notes, Trackwise, PDM), providing support and training to users to maximize system efficiency.

Ringsted, Sjælland, Danmark

During my internship in Dagrofas Quality Department, I was responsible for developing a comprehensive quality document that detailed product categories, associated risks, specific requirements, and relevant legislation. This document was meticulously crafted using industry standards, Dagrofas product specifications, internal requirements, and applicable regulations.For my final project, I validated this quality document through a detailed analysis of microwave popcorn, chosen for its complexity due to multiple ingredients and packaging. I also identified opportunities for packaging optimization and reduction.Additionally, I participated in a two-day Insight Food & Health conference, focusing on sustainable food materials and current food legislation.

Sorø, Sjælland, Danmark

Afløser som selvstændig morgenkok og ekstra hænder ved store selskaber.

Roskilde, Sjælland, Danmark

Problemløsning, planlægning og mødeforplejning

København, Hovedstaden, Danmark

In the canteen at Berlingske Media

København, Hovedstaden, Danmark

Apprentice chef at both the Ministry of Finance in Copenhagen and Metroselskabet in Vestamager

Herlev, Hovedstaden, Danmark

Kongens Lyngby, Hovedstaden, Danmark

Lean Management In Practice With A Yellow Belt Six Sigma Certification

Activities and Societies: LEAN-ledelse i praksis med en yellowbelt Six Sigma certificering

Conflict Management And Communication

Intern Auditor, Kvalitet Iso 9001:2015

The Occupational Health And Safety Training

Administrator In D4Infonet, D4Flow And Cover Layout

Professionel Scrum Master

Completed a course focused on optimizing development processes and enhancing product quality using Scrum's agile methodologies. The course.

Process Technology With A Specialization In Food Technology

First semester: Analyzed cleaning procedures, including CIP (Clean-In-Place) systems, with an in-depth focus on the mechanisms of cleaning.

Gastronomist Specializing In Catering

- Selection and Purchasing of Goods: Efficient management of procurement by considering consumption, quality, economy, and storage.

Biology At B Level, Chemistry At C Level, And Mathematics At C Level

Biologi på niveau B Kemi på niveau C Matematik på niveau C

Social And Health Care Assistant

⋅ Fokus på sygepleje, forebyggelse, sundhedsfremme, rehabilitering og hygiejne. ⋅ Medicineringhåntering. ⋅ Motiverer, vejleder og guider.

Social And Health Care Helper

⋅ Professionel omsorg ⋅ Forflytning ⋅ Førstehjælp ⋅ Pleje ⋅ Praktisk hjælp