Reports To: QA Team Leader

General Overview of the Role

The Quality Specialist (New Product Introduction) will lead on all quality related aspects of multiple projects and ensure key aspects are delivered to meet project deadlines. The role will involve working with design teams throughout the design process to ensure that requirements of current standards and regulatory requirements are being met.

Duties and Responsibilities

• Collaborate with design project team members to achieve key deliverables to meet project deadlines.
• To identify, lead and plan on quality related project deliverables
• Work with the project teams to plan and organise quality related deliverables and requirements
• Participate and lead in project risk analysis (e.g., establishing risk documents such as FMEA)
• Work with project teams to select and evaluate suppliers during the design phase
• To carry out supplier audits as required during the design phase
• Work with project teams to identify and carry out design and process validations during the design process, including the design transfer stages (IQ/OQ/PQ)
• Guide and advise the design team on quality related design requirements with respect to relevant standards and regulatory requirements   
• Review/ carry out gap analysis of existing DHFs/Technical Files to identify testing requirements to comply with current standards
• Identify and plan testing strategies for various quality related requirements (eg. sterilisation and cleaning methodologies)
• Write technical justifications and validation reports
• Write/collaborate in writing clinical evaluations to meet current regulatory requirements

Any other routine duties as assigned which may include:

• Managing customer complaints from receipt to closure
• Developing, improving and writing new processes and SOPs as required
• Participating in NCR/CAPA reporting and investigations
• Managing calibration schedules and liaising with other departments to ensure all equipment is calibrated
• Routine environmental monitoring of the clean rooms
• Internal quality compliance audits

Any other duties as assigned by Management

Required Skills, Experience and Education
Skills/Experience

• Effective communicator with good interpersonal skills
• Internal and external customer oriented/focused and able to develop and maintain good customer relationships
• Well organised and able to manage documentation
• Plans, schedules, and completes tasks/projects to meet deadlines and corporate objectives
• Is a team player and able to work in a cross-functional team
• Commercially aware
• Knowledge/understanding of FDA regulations (including 21CFR 820), EU Medical Device Directives and Canadian Medical Device Regulations required.
• Knowledge of the requirements for international quality systems, including ISO 13485:2012, 9001:2008 required.
• Must have clean room and sterilization knowledge including knowledge of standards relating to cleaning and sterilisation of medical devices.
• Experience in the manufacture and design of Class IIa and IIb sterilised Medical Devices  
• At least 2 years relevant experience in a similar role in the Medical Devices Industry

Education

Minimum HND/Bachelor’s Degree required, preferably in a Science or Engineering field

Desirable Skills/Education

• Lead auditor in 9001 & 13485