I am currently recruiting for a head if QA for a multinational highly scientific client in Scotland, this business has gone from strength to strength in the last 4 years and is now looking to bring on a highly skilled QA professional to maintain compliance through future growth plans.
• Management of QA Compliance processes and associated personnel
• Maintenance and development of robust and compliant CAPA, Complaint, NCR, Internal Audit and
• Supplier Management processes
• Development of a team of trained Internal Auditors within the facility ensuring timely and effective execution of the Internal Audit programme.
• Development and maintenance of a process based QMS, with published KPI’s for all functional areas
• Coordination of all customer and regulatory body audits.
• Development of QMS Awareness Training programmes and execution across the facility
• Provision of regular communications and reports to senior management, functional leaders, customer and regulatory bodies as required
• Complaints investigation and management including MDV/MDR/ORA reportability decisions
• Execution of regular Complaint Review Board meetings
• CAPA and NCR management and execution of regular CAPA/NCR Review Board Meetings
• Liaison with RA and Clinical Services with respect to MDV/MDR reporting and communications
• Supplier risk assessments, supplier audits and maintenance of supplier ratings
• Relevant Science/Engineering Degree. Post graduate qualification advantageous
• Extensive and proven experience in Quality Management Systems in a similar role within a medical device environment
• Experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
• Experience of managing and motivating personnel, managing by objectives and conducting personnel appraisals/performance reviews
• Experience of Medical Device Directive and related regulations, preferably for Class III devices
• Experience of hosting regulatory and customer audits, including Notified Body audits and FDA Inspections
• Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices including FDA and MHLW regulations
• Strong analytical and problem-solving skills
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 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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