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HR Manager at Goodman Medical Ireland Ltd
General Description
We are seeking a skilled Validation Engineer to design, document, and release Test Method Validation Operating Procedures. This role involves training and supporting these procedures through adoption and into maturity, compliant with ISO, PMDA, and FDA requirements, related to the manufacture of PTCA catheter products. The engineer will design, schedule, and execute test method validations from incoming inspection, in-process, and finished product inspection associated with PTCA catheter products. Additionally, the engineer will provide early stage consultation to other departments on test method requirements at project proposal stages and support other departments in designing, documenting, performing, and improving test methods and inspection procedures.
The role requires using relevant statistical bases to demonstrate that the test methods are accurate, precise, and reliable and participates in the development of new test methods where required to meet these criteria.
The engineer will also support other validation activities with subject matter expertise and guidance, reviewing external testing partners' methodologies, protocols, and reports for compliance with relevant regulatory requirements.
Role & Responsibilities
* Working as part of a cross-functional project team, the engineer will be responsible for the site test method validation related activities;
* Estimation of validation timelines & resource requirements;
* Generate and approve standard operating procedures for test method validation;
* Ensuring compliance of test method validation process with ISO, PMDA, FDA regulatory requirements;
* Generate and approve test methods Master Validation Plan & Report;
* Generate and approve test method validation protocols & reports;
* Actively involve in the development of risk assessments (FMEA);
* Co-ordinate & execute validation activities;
* Provision of project progress updates to the Site Validation Lead;
* Escalate validation related issues & risks in a timely manner;
* Perform statistical analysis of validation results for comparison to acceptance criteria;
* Train and mentor team members on validation processes and procedures.
Education Requirements
* A minimum of 5-8 years working in a relevant medical device manufacturing environment;
* Practical experience & good working knowledge of test methods relevant to catheter-based delivery devices, preferably PTCA balloon catheters;
* Relevant third level qualification in Science or Engineering (Level 8);
* Knowledge of medical device manufacturing from a validation, regulatory, or testing perspective;
* Excellent analytical & problem-solving skills;
* Excellent numerical skills and attention to detail;
* Proven ability to work as part of a multi-disciplinary team in a dynamic environment;
* Proven track record of committing to, and meeting deadlines;
* Effective communicator with all levels of the organisation and interaction with customers;
* Knowledge of the regulatory framework around medical device validation requirements.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Medical Device
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