What you need to know
An innovative and growing medical devices company in Roscommon who provide their clients with bespoke and high-quality products is currently seeking a Senior Quality Assurance Engineer to manage their quality processes.
The company provide tailored technical solutions and manufacturing services to an array of leading med-tech companies. They pride themselves on their meticulous and professional approach throughout the manufacturing process and have an outstanding track record of developing new products from concept generation through to commercialisation.
As a Senior Quality Assurance Engineer you will report directly to the Quality Engineering Manager and will seek to maximise production quality performance.
This is a Permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
- Implement company policies and procedures regarding quality standards.
- Maintain and seek to improve existing Quality Management processes.
- Maintain accurate quality records, data analysis and documentation.
- Lead and drive QA initiatives within area of responsibility.
- Represent quality interests and concerns on project teams.
- Deliver Quality support to your assigned Customer and project teams.
- Manage Quality Engineering activities for the introduction of new product lines and existing product lines.
- Manage process, product and sterilisation validations.
- Lead root cause investigation of quality issues
- Ensure quality inspection instruments are accurate and regularly calibrated, tested and audited.
- Conduct internal audits and external audits as required.
What are we looking for?
- Degree in Quality Assurance or similar discipline.
- Minimum of 6 years’ experience in a Quality Engineering role ideally within the medical devices industry.
- Ability to lead by example and demonstrate best practices.
- Strong oral and written communication skills
- Proficient with Microsoft Office.
- Knowledge of ISO 13485, ISO 14971 and QSR 21 CFR Part 820 standards.
- Strong ability to analyse statistical information.
- Ability to problem solve and provide solutions.
Apply for this job now or get in touch with Oliver at email@example.com
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