Job Purpose

• Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality.
• Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
• Promoting and effecting compliance to quality, business and health & safety systems and market/legal regulations.
• Analyzing, reducing and managing risks associated with the design, use, and manufacture of medical devices.
• Providing expertise in BSC’s product development systems to project teams
• Supervising, leading and coaching members of the design assurance department

Key Responsibilities

General

• Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
• Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance with product development activities to internal and external requirements.
• Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
• Continually seeks to drive improvements in product and process quality.
• Implement, maintain and update procedures that ensure that R&D documentation constantly meets Product Development Process and Design Control requirements.
• Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.

Technical

• Provides regulatory compliance, risk management, design control, and quality systems expertise to the team.
• Identifies and resolves complex exceptions to work assignments.
• Summarises, analyses and draws conclusions to make appropriate decisions from test results or other process related findings.
• Fully conversant with verification/validation techniques, risk management, statistical techniques, and associated regulatory requirements
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.
• Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.

Leadership

• Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in the Product Development Process (PDP), Recertification, Risk Management and Design Control SOPs.
• Co-ordination of team activities in line with departmental objectives and project goals.
• Supervision and development of staff reporting to them in line with departmental and project goals.
• Uses opportunities in project assignments to develop other team members.
• Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.
• Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class.
• Is a good team member, committed to the project's success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
• Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures