QA/QC Manager

wherewework.bg on behalf of:Horizons BulgariaQA/QC ManagerOur 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 Katuntsi, Bulgaria, we are looking for a:QA/QC ManagerAbout the role:The QA/QC Manager will play a crucial role in ensuring the quality and safety of our medical devices throughout the manufacturing process.Job Responsibilities:Quality Assurance: Review and approve manufacturing documentation (batch records, device history records, etc.) to ensure compliance with regulatory requirements and internal standards. Conduct in-process inspections during production to monitor compliance with specifications and procedures. Perform final product inspections, including visual inspection, dimensional measurements, and functionality testing. Investigate and document any non-conformances or deviations from specifications. Assist in developing and implementing quality improvement initiatives. Participate in root cause analysis investigations to identify and address quality issues. Quality Control: Perform incoming inspection of raw materials and components to ensure compliance with specifications. Conduct calibration and verification of measuring equipment to ensure accuracy. Assist in the development and maintenance of quality control procedures. Participate in the validation and qualification of equipment and processes. Documentation: Prepare and maintain accurate and complete documentation, including inspection reports, non-conformance reports, and quality data. Maintain the integrity of quality records. Assist with the creation and updating of quality system procedures. Regulatory Compliance: Stay updated on applicable regulations and standards related to medical device manufacturing (e.g., FDA, ISO 13485). Support the company’s compliance efforts through audits and inspections. Qualifications:– Academic Level: Bachelor’s Degree in Science, Pharmaceuticals– Experience: 2+ years of experience in QA/QC in a medical device manufacturing environment.– Fluent English.– Must be customer oriented and work well with varied personalities inside and outside of the company.– Ability to read, write and handle basic math problems.– Ability to manage projects.– Strong written and oral communication skills.– Analytical skills.– Strong knowledge of MS Excel, Word and power point.Personal Requirements:– Attention to Detail– Problem-Solving– Communication Skills– Integrity and Ethics– Adaptability and Flexibility– Organization and Time ManagementIf you are interested, please, send your CV with a recent photo.Horizons is a leading recruitment company specializing in expert and middle management positions with 20 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.Apply for this position