Quality Manager

Location: Plymouth

Our client, a leading medical device company, is seeking a dynamic and experienced Quality Manager to join their team. As the Quality Manager, you will play a vital role in ensuring the delivery of the Quality Strategy and driving continuous improvements.

If you are passionate about quality and have a strong background in the medical device industry, we want to hear from you!

Responsibilities:

• Provide leadership to the site quality function, including quality systems, quality engineering, and QC analytical and Microbiology.
• Manage the successful delivery of the Quality Strategy to achieve corporate goals and objectives.
• Ensure compliance with MDSAP regulations, and the Medical Device regulation (MDR).
• Prepare and manage the budget for the site quality function.
• Ensure effective delivery of new product development by overseeing quality deliverables and compliance with design control and validation requirements.
• Make decisions related to quality issues, conduct root cause analysis, and implement corrective actions to avoid product recalls.
• Review and approve supplier and customer quality agreements to meet compliance and operational requirements.

Requirements:

• Bachelor's degree or equivalent in a scientific discipline or 4+ years of experience in the medical device or pharmaceutical industries.
• Demonstrated leadership experience in previous roles.
• Proficient knowledge of applicable Quality System Regulations and ISO quality requirements.
• Familiarity with the Medical Device regulation.
• Strong knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
• Proficiency in spreadsheets and word processor applications.
• Solid understanding of statistical methods, sampling plans, and statistical analysis.
• Experience with analytical methods, equipment, process, software, cleaning, and/or facility/utility validations.

If you're interested to know more, please get in touch!