Quality Manager - Nottingham

About Our Client

My client are a highly successful manufacturer, who supply into the medical/pharmaceautical industry.

This is a full-time on-site role, based near Beeston, Nottinghamshire.

• Manage and maintain the organisation's QMS, ensuring it meets customer, internal, and regulatory requirements, including overseeing internal and customer audits.
• Lead the investigation and resolution of customer complaints and quality concerns, providing detailed reports and corrective actions.
• Oversee quality-related issues in manufacturing, determining root causes, corrective actions, and implementing solutions.
• Lead investigations on nonconformances, product incidents, and regulatory requirements, ensuring effective documentation and communication.
• Report regularly to senior management on QMS performance, audits, KPIs, and areas for improvement, while leading quarterly management reviews.
• Manage the Supplier Management program through risk assessments, audits, and compliance with internal standards.
• Develop and maintain Quality Control (QC) processes to ensure effective inspections and compliance.
• Drive continuous improvement initiatives using lean/Six Sigma methodologies, advancing the quality programs to meet global customer needs.
• Build and lead a talented team, focusing on hiring, training, and development to meet department and company goals.

• Extensive knowledge of ISO, cGMP, and medical or pharmaceutical regulatory requirements.
• Experience in ISO 9001 or 13485 QMS implementation, auditing, risk management, and corrective action.
• Strong background in statistical process improvement, root cause analysis, and supplier/vendor management.
• Excellent communication skills, both verbal and written, with the ability to present to various stakeholders.
• Ability to thrive in a fast-paced environment, juggling multiple priorities effectively.
• Deep understanding of global pharmaceutical and biotech regulations.
• Expertise in Quality Systems like ISO 9001, ISO 13485, 21 CFR Parts 210/211, or Part 820.
• Six Sigma Certification, ASQ Certified Quality Engineer, or equivalent experience.
• Strong leadership and MS Office skills.
• Bachelor's degree in Life Sciences, Business Management, or related field.
• 5+ years of experience in a manufacturing or quality environment, with a solid understanding of QMS standards and regulatory requirements.
• Proven track record in Root Cause analysis, Corrective Action, and Process Improvement.

What's on Offer

The successful candidate for this Quality Manager position will be offered up to £55,000 plus package (4% pension contribution, Death in Service x3, 25 days holiday plus BH)