My client is a family owned rapidly expanding business that manufacture a range of Medical Devices in both Sterile and non-sterile environments. They are now looking to take on a Head of QA/RA to make sure that future growth is met with a solid compliance record. This person will have one direct report but will be responsible for Championing quality throughout the business and reporting and dealing with issues with senior management;
• Ensure knowledge is kept up to date on all industry best practice and FDA or regulatory requirements
• Direct and coordinate the company’s quality program, including ISO13485/FDA QSR systems and procedures
• Liaising with Suppliers and Customers – Complaint Investigations & reporting
• Generation and maintenance of QMS Documentation/MDD Technical files
• New Product Development and New Process Introduction
• Process Validation, Statistical Analysis & Capability Studies
• Internal / Supplier / Customer and Notified Body Audits
• Root cause Analysis and Corrective & Preventive Actions
• Implementation of Lean principles (Identification & elimination of Waste)
• Experience of influencing people with a demonstrable track record of making a difference within an organization.
• A working knowledge of the ISO 9001:2008, 13485:2003, standards, FDA QSR, and the Medical Device Directive, ideally with previous experience of working in a senior quality role within the Medical Devices or Pharmaceutical Industry.
• Excellent understanding of customer relationship management and customer service
• Experience in Product and Process validation, Statistical analysis and process capability studies.
• A working knowledge of Kaizen, Six Sigma, Lean, Problem solving, Continuous Improvement methodologies, tools and techniques.
• Experience in CAPA management and change control
• Validation experience including CSV.
• Extensive experience in Quality Systems management.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call on 07772338996 or contact the office on +44 203 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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