Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances.
Responsibilities:
* Write and execute validation protocols and reports for new product introductions, and revalidations including IQ, OQ and PQ ensuring compliance with regulatory standards (ISO13485 etc.)
* Complete data analysis on validation data for the generation of reports and make informed decisions/recommendations based on this analysis.
* Lead the qualification of new and existing manufacturing equipment to ensure proper installation, and performance.
* Ensure traceability and audit readiness of all validation activities for internal and regulatory audits/inspections.
* Provide mentorship to other colleagues to strengthen validation knowledge within the organisation
* Assist with maintaining the quality system to international standards ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOP's and revision of existing documentation within the quality management system
* Partake as a key team member in customer and regulatory audits as required.
* Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.
* Monitor vendors and issue NCMR's where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching Mergon product.
* Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.
* Manage investigation and closure of Validation Deviations, Non-conformances and CAPA's, including support of the investigation processes when not the owner.
Requirements:
Bachelor's Degree in Science, Engineering or a related field
Minimum 2 years' experience as a validation engineer in injection moulding, blow moulding or medical device manufacturing.
Strong background in statistical analysis (minitab), SPC and validation methodologies.
Strong interpersonal, problem solving and attention to detail skills.
The successful candidate should be able to work as part of a team as well as on their own initiative.
Ideally have exposure to the requirements of ISO 13485.