Quality Engineer - Validation

• Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements. These primarily consist of; Co-ordination of design control, validation and change control programmes. Performance of Risk Assessments and associated Risk documentation.
• Assist in the investigation and coordination of design control, validation and change control related customer complaints/Non-Conformances, assess need for implementation of effective corrective/preventative actions or update to the risk management file.
• Review and approval of all documents generated in Validation Management System (M-Files).
• Management of key site projects and liaison with all key internal and external stakeholders. Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly and quarterly reports etc.
• Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training where relevant, including M-Files system and Validation Program Training.
• Ensure management are kept informed of all system failures on a regular basis to ensure corrective/preventive action is taken where necessary.
• Ensure implementation and compliance with relevant regulatory requirements.
• Audit the Quality System with other management personnel where required. Support of Supplier Audits and internal audit programme where required.

• Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbott's EHS Program
• Ensure to report any work related injuries or illness to employee health and assist in the investigation.
• Active participation and support of Abbott's EHS programs, and attend EHS training as assigned. Meet EHS plant goals

• Educated to degree or diploma in an engineering, science or quality-related discipline, or an equivalent combination of education and work experience.
• Strong working knowledge of quality systems regulations (IS013485/lS09000) or individual elements within the regulations such as; design control, production and process controls, change control, lean principles etc.
• Proven Validation skills in a regulated environment.
• Risk management skills — including risk assessment and an understating of IS014971.
• Proven project management and organisational skills.
• Excellent interpersonal/communication skills.
• Enthusiastic and energetic with the ability to integrate quickly into a team environment
• Self-starter with proven ability to work on own initiative.
• Demonstrate flexible and innovative approach to work
• Previous experience of working in a multinational and/or regulated medical device manufacturing organization is desirable
• Previous Audit Experience, End to End sterilisation experience, experience in relation to Medical Device Regulation MDR 2017/745 is desirable

Abbott