Quality Assurance/Quality Control Manager

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 Katuntsi, Bulgaria, we are looking for a:

QA/QC Specialist

About the role:
The QA/QC Specialist 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: Fresh Graduates with Bachelor’s Degree in Science, Pharmaceuticals
– Experience: Fresh Graduates or up to 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 Management

If 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 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.