Position Title: Quality Manager
Reports to: Head – R&D
As a quality manager, you’ll need to:
• devise and establish company’s quality procedures, standards and specifications
• review customer requirements and make sure they are met
• work with purchasing staff to establish quality requirements from external suppliers
• set standards for quality as well as health and safety
• make sure that manufacturing or production processes meet international and national standards
• look at ways to reduce waste and increase efficiency
• define quality procedures in conjunction with operating staff
• set up and maintain controls and documentation procedures
• monitor performance by gathering relevant data and produce statistical reports
• review existing policies and make suggestions for changes and improvements and how to implement them
• measure performance and identify any areas of weakness, recommending and implementing improvements
• liaise with other managers and staff and provide training, tools and techniques to enable others to achieve quality standards
• assess the effectiveness of changes made
• train and manage a team of quality control technicians.
• Minimum of 5 years of Medical device QA/QC experience
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Quality Management experience in a manufacturing/production environment.
• Conscientious and responsible
• A keen eye for detail and a results driven approach
• Strong communication and presentation skills.
• Excellent organizational and leadership skills
• Proficient in MS Office
• In-depth understanding of quality control procedures and relevant legal standards
• Excellent math abilities and working knowledge of data analysis/statistical methods