Quality Manager - Nottingham
Michael Page 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.
Job Description- 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)
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