Description
I have an immediate opening for a Quality Assurance Engineer with a leading medical device company based in Clonmel Co. Tipperary. This is an excellent opportunity to join a fantastic company on a permanent basis with a very competitive salary and benefits package on offer.Key Responsibilities
1. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying and bounding data to support implementation of complex and documenting release criteria.
2. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and Failure Mode Effect Analysis (FMEA).
3. Develops process monitoring systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
4. Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
5. Assists in creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools and materials.
6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
7. Participates in corrective and preventive action activity.
8. Participates in Field Discrepancy Notification (FDN) investigations.
Requirements
- National Framework of Qualifications level 7 qualification in a relevant discipline and 4+ years of related work experience, or an equivalent combination of education and work experience.
- (Technical/Business Knowledge (Job Skills)) Wide application of technical principles, practices and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- (Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- (Planning/Organisation) Plans and organises non-routine tasks with approval. Initiates or maintains work schedule. Establishes priorities of work assignments
If you are interested in this role and feel please apply directly to this advert or contact Derek Sheridan on for further details.