SalaryLocationLimerickIndustryPharma, Biotech & HealthcareJob Description
responsible for the overall quality engineering of new product development and product maintenance through the application of Quality engineering skills.
The summarised responsibilities of this role will include;
- Representing the Quality management Function on Project Teams for both new product development and existing products.
- Playing an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements.
- Defining appropriate metrics to measure progress and to define yearly objectives.
- Resolving complex problems and driving quality engineering improvements.
To be considered for this position, candidates will need to have at least 10 years’ experience in either the Healthcare/Pharmaceutical/Biologics or Medical Device sectors. You must also have at least 3 years Management exposure.
It is important for the success of this role that you will have past experience working within a cross functional environment where you work extensively with remote teams and colleagues around the world.
General understanding of Design Control, DFSS is important along with experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management. Other important regulatory
Standards include: ISO 13485, QSR, 21CFR820, ISO 60601, 62304, 62336