Our client is Pharmaplast – a company that specializes in manufacturing advanced wound care dressings, retail tapes, bandages, cosmetics and all their raw materials. They have a customer base of 400, in 85 countries worldwide.
For their newest location in Katunsi, Bulgaria, we are looking for a:
Provides quality management leadership across the business within a highly regulated medical devices environment.
Ensures compliance of the QMS with the applicable Standards and Regulations.
• Securing and maintaining the Documentation management system on daily basis.
• Organize, archive and maintain documents on a daily basis.
• Accurate efficient preparation of documents on a daily basis.
• Scan and upload documents on QMS shared folder on a daily basis and one drive.
• Notify concerned personnel of updated documents versions in case notifying is needed
• Planning of internal audit plan in the Amria Free Zone Site annually.
• Conducting internal audit rounds according to schedule.
• Developing recommendations and reports based on audits and presenting these ideas to management when needed.
• Responsible for the arrangement/follow-up related to gamma sterilization validation process and routine process.
• Review and record the “audit activities” for the supplier’s performance score code.
• Undertake regular internal and process audits of the QMS.
• Documentation management system for all company documents.
• Train others in all aspects of the quality system and application of procedures.
• Others: to carry out any tasks given to him by the top management to achieve the objectives and any orientations in favor of the work.
– Academic Level: Bachelor’s degree in science, business administration or any relevant field.
– Experience: 5+ years of solid experience in QMS Field, 10+ years of experience in Quality control.
– Planning and organizing skills
– In-depth knowledge of MDR guidelines and ISO standards and other international regulations
– Excellent knowledge of ISO 13485, CE and FDA requirements
– Strong background and experience with audit methodologies and techniques
– Prior success conducting external or internal audits
– Proven track record of preparing for and managing successful Quality audits/inspections
– Fluency in written and spoken English
– IT knowledge (word, excel, power point)
– International experience and multi-cultural mindset would be considered a plus
– Attention to details
– Communication skills
– Time management
– Team work
– Decision-making skills
If you are interested, please, send your CV with a recent photo.
Your personal information will be used only for the purpose of the recruitment process and will be treated with confidentiality and respect. Confidentiality is guaranteed and protected by law.
Horizons is a leading recruitment company specializing in expert and middle management positions with 18 years of experience in the Bulgarian market. Our team consists of business-oriented consultants with industrial specialization, a professional understanding of the business trends and a pro-active approach towards recruiting and hiring through different methodologies and innovations.
Horizons owns license No 2118 from 27.09.2016.