Quality Manager

Stem Recruitment have a fantastic opportunity for an experienced Quality Manager to work for an innovative life science company. We are recruiting for a biotech startup focusing on advancing applications for novel long read RNA sequencing technologies. They are developing both biochemical and bioinformatic technologies to explore the hidden side of the transcriptome. They are using these technologies to find solutions for some of the most pressing issues in human medicine, agriculture, and fundamental biology. With an office in Midlothian, the company also offers the flexibility of hybrid working. This opportunity will allow you the creativity to play a crucial role in building compliance with ISO 13485 and/ or 21 CFR 820 regulations, as well as implementing and maintaining a robust quality management system tailored to the needs of a small biotech startup. You will be responsible for developing, managing, and continuously improving quality processes and systems to support the company's objectives in product development, manufacturing, and commercialisation.

This opportunity will allow you the creativity to play a crucial role in building compliance with ISO 13485 and/ or 21 CFR 820 regulations, as well as implementing and maintaining a robust quality management system tailored to the needs of a small biotech startup. You will be responsible for developing, managing, and continuously improving quality processes and systems to support the company's objectives in product development, manufacturing, and commercialisation.

Key Responsibilities;

• Develop, implement, and maintain a Quality Management System (QMS) in compliance with ISO 13485 requirements.
• Ensure the company's activities, processes, and products comply with relevant regulatory standards and guidelines, including ISO 13485.
• Oversee the creation, review, approval, and maintenance of quality-related documentation, including standard operating procedures (SOPs), work instructions, forms, and templates.
• Plan, conduct, and follow-up on internal and external quality audits to assess compliance with regulatory requirements and company policies.
• Establish and maintain processes for evaluating, selecting, monitoring, and auditing suppliers and contractors to ensure they meet quality standards.

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., biology, chemistry, biomedical engineering).
• Minimum of 5 years of experience in quality assurance or regulatory affairs roles in the medical device or biotechnology industry.
• In-depth knowledge of ISO 13485 or 21 CFR 820 regulations and their application in a manufacturing environment.
• Experience with quality management systems, quality audits, CAPA management, and risk management.
• FDA experience.

If this is of interest, please get in touch for a confidential conversation.