Senior Quality Engineer:

Our client a high potential medical device start up are currently seeking a Senior Quality Engineer to join their team. The role is stand alone and has the potential for this position to develop into a Quality Manager Role. The Senior Quality Engineer will provide experienced ongoing Quality support to internal design and development team in addition to managing and advising suppliers on quality performance. The primary objective of the Senior Quality Engineer role is to ensure the requirements of the Quality Management System are met. This role will take the lead in implementing new procedures and improving the quality assurance function throughout the business.



Role/Responsibility

• Management of the Design Control Process from a Quality perspective and provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation.
• Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
• Have the responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
• Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
• Be a leader in QSR, ISO/MDR standards and be constantly aware of best industry practices.
• Have some expertise in regulatory requirements.
• Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Champion continuous improvement and innovation from a quality perspective within the department from vendor selection through to management of outsourced processes.
• Be an effective team member, be fully motivated to achieve and demonstrate best practices in line with the department.
• Provide Training to all personnel on the Quality Management System.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.

• Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
• A minimum of 5 years’ experience in a similar role (Highly regulated environment)
• Proven track record in leading quality within a medical device manufacturing company.
• Ability to manage quality related projects.
• Proven track record in people management.
• Team player with strong work ethic and positive mentality.
• Thorough knowledge of applicable regulatory requirements (ISO 13485, FDA 21 CFR 820, etc.)
• Excellent communication skills both verbal and written.
• Excellent attention to detail.