Core Purpose: The ideal candidate will fulfill the quality assurance responsibilities of product development and related sustaining engineering activities, including creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality. Directly involved in compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.You will also be promoting and effecting compliance to quality, business and health & safety systems and market/legal regulations and analysing, reducing and managing risks associated with the design, use and manufacture of devices. Providing expertise in product development systems to project teams. There will be Supervising, leading and coaching members of the design assurance department also
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 of 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
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.
Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
Identifies and resolves complex exceptions to work assignments.
Summarises, analyses, draws conclusions and makes 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.
Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in 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 policies and procedures.
Qualifications & Experience:
HETAC Level 8 in a relevantSTEM disciplinewith a minimum of 5 years’ experience in a similar role.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Proven ability to work well as part of a team & on own with minimum supervision.
Knowledge & understanding of EN ISO 5840-3 is essential.
Material knowledge of nitinol and any experience with testing of nitinol is desirable.
Material knowledge of animal origin (bovine or porcine) is desirable.
Basic knowledge/understanding of valve testing/kinematics.