Quality Manager

Short Description

Our client - a fast-growing and innovative company in the medical devices - is seeking an experiencedQuality Managerto lead and further develop their Quality Management System (QMS).

Description

• Maintaining ongoing compliance with ISO13485, GMP, CE mark, and CFR standards for medical device and pharmaceutical manufacturing, as well as ISO27001 for internal software systems. • Leading continuous quality improvement initiatives across all departments. • Monitoring and reporting on KPIs and operational efficiency. • Driving Six Sigma process optimization and implementing process controls. • Acting as the main contact for notified bodies and representing the company during external audits. • Develop and execute a 12-month Quality Plan aligned with company objectives. • Manage compliance and continual improvement of the QMS. • Conduct internal audits, lead Quality Management Reviews (QMRs). • Liaise with suppliers, ensuring alignment with QMS requirements and conducting supplier audits when needed. • Prepare and maintain Quality Procedures (QPs), Work Instructions (WIs), and Records. • Train new employees on QMS structure, procedures, and compliance standards. • Maintain precise and well-organized documentation in line with regulatory expectations.

Requirements

• Relevant academic background - Technical university degree or comparable. • 3+ years of experience in Quality Assurance in a manufacturing environment. • Strong knowledge of ISO9001, ISO13485, GMP, and/or ISO27001. • Industry-relevant production experience in quality systems, procedures, and inspection methods. • Good level of English (minimum B2). • Strong proficiency in Microsoft Excel and/or Minitab. • Broad knowledge of the principles and regulations related to quality assurance. • Strong analytical and problem-solving skills. • Excellent project management and communication skills, with experience engaging internal teams and external stakeholders. • Experience in startup or scale-up environments is preferred.

Offer

• Motivating remuneration and additional social package. • Opportunity for long-term realization in an international company. • Work in a manufacturing environment with high standards. • The opportunity to work alongside a passionate, driven, and international team of top performers, united by a shared commitment to excellence and innovation.If you are passionate about advancing quality and innovation, and your background reflects the experience we’re seeking, we look forward to exploring how you can contribute to our client's continued success.Only shortlisted candidates will be contacted. Confidentiality is guaranteed!Only shortlisted candidates will be contacted. Confidentiality is guaranteed!Manpower Bulgaria has License № 2033/20.04.2016 for providing human resources services.