Quality / Regulatory Manager

About Us:

Envaste Ltd is active in the field of medical science and specialized in the manufacture and distribution of urology and endoscopy devices.

Our company and production site is located in the heart of the Island of Mauritius.

The Role:

• Sustain and develop the existing Quality Management System including the procedures, WIs and protocols.
• Responsibility for the development of the ISO13485:2016 quality system. This includes ensuring that all quality systems are operational and effective, focused on continual improvement and compliance to market standards.
• Conduct risk assessments in work flows and procedures to ensure effective and repetitive outputs are achieved in manufacturing.
• Police manufacturing processes ensuring sufficient quality workmanship
• Conduct internal audits to identify process gaps and improvements including preparing a detail plans for implementation of new recommended processes and procedures. This will assume total ownership of the proposed procedure for implementation.
• Provide Quality leadership to environmentally controlled manufacturing and production areas.
• Manage and prepare site quality systems including QMS, CAPAs,, etc.
• Participate and lead internal and external supplier auditing, customer complaints, product release, validation, 5S auditing and actioning, change control and QC testing.
• Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEAs, activities within the team
• Support supplier management in Material Quality, Certification and Validation activities in existing and new markets.
• Develop and implement Inspection Monitoring and Process Control procedures to improve operational efficiency.
• Lead and execute Validation/Qualification activities within the Team. Validation documentation authoring and review.
• Work within the business unit cross functional team to continuously improve its achievement of quality and business goals.
• Provide training in Quality Processes, Procedures, Practices & Techniques to the extended production and technical team to enhance knowledge and quality focus in the company.
• Implement and sustain “Lean” tools and methodologies throughout the business.
• Leading and implementing various continuous improvement projects for the company within Quality and Manufacturing operations.
• Enhancing customer relations and perception through potential visits for the purpose of working with customers to provide technical support.

The Person:

• The successful candidate will ideally be qualified to a degree level in a quality or engineering related discipline with a minimum of 2 years relevant industry experience.
• Previous experience in a quality engineering or engineering role, with a customer-facing element is required.
• Excellent analytical, problem solving and interpersonal skills are required with an ability to effectively communicate improvement projects to management and customers.
• Experience in engineering/manufacturing regulated environment is preferable.
• Experience in managing people and providing leadership and direction Quality people
• Ability to manage and work in a fast paced and dynamic working environment is essential.
• Experience and background in LEAN manufacturing environment preferable
• Some travel may be expected as requested.