Job Description

The role provides focus for the Global Quality Management System (QMS) working closely with manufacturing and other departments /functions to support, develop and promote consistency, continuous improvement and compliance with Global/Site quality and business requirements. You will be expected to take initiative and support change across the business in order to promote both compliance, product quality improvements and efficiency.

The role is fixed term for 6 months initially.

Responsibilities:

• To support the generation of Certificates of Analysis to meet compliance and customer requirements for all appropriate products to facilitate their release.
• To check batch records during QA 3 tier review, ensuring GDP and critical manufacturing processes executed as stipulated on processing documents and allow quality assurance of released material through SAP for release to customers.
• To provide QA support to allocated area on site with respect to documentation needs/general QA support/training/problem records inclusive of archiving tasks.
• This position supports investigations into product and process issues and provides QA assistance with the provision and documentation of solutions through the on-site electronic management systems i.e. Trackwise.
• To support the internal audit processes by assisting lead auditors prepare for audits and checking that ISO13485 documented processes are followed at all times in all areas.
• To take part in practical process improvement initiatives in order to improve product & process improvements.
• To assist NPIs as a team member on product introductions.
• To assist with document and ECO approvals by reviewing submissions ensuring ECOs are fit for purpose and appropriate documentation is attached for review.
• This position supports the measuring and monitoring of performance of business KPI's including collating and sharing of information/data and trending as appropriate through reports and thus follows up on improvement opportunities.
• This position will be able to take part in risk assessments (PFMEA/FMEA) to assist in improving both product and processes.
• This position will be a trained internal auditor (ISO13485) and be competent to support the internal audit program.

Required Knowledge, Skills, and Abilities

Degree in a scientific discipline or equivalent experience in a relevant discipline. Knowledge of 13485 or equivalent standard an advantage. Experience of ISO14971/FMEA/PFMEA an advantage. Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts). Experience of CAPA processes & problem solving within Process/Product Improvement multi-functional teams. Ability to work on multiple tasks at any one time. Excellent communication and report writing skills. Ability to recognize deviation from requirements and understanding risks when decision making. Experience of office packages and general computer skills – knowledge of Trackwise/SAP/Agile an advantage. Ability to challenge existing approaches to compliance in order to seek improved ways of working. Ability to coach and influence others is essential. Travel requirements – some travel maybe required – 10% max.