Design Quality Engineer (12 mth contract)

As our Design Quality engineer, your Key Accountabilities will involve:

• Review new and modified product designs for quality characteristics, including     manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
• Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.

Skills & Qualifications:

Minimum requirements:

• BSc Mechanical engineering or related discipline with 3 years’ experience in a similar role
• Good verbal and written communication skills including protocol / report development and technical presentations.
• Experience Risk Management ISO 14971
• Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
• Experience of verification/validation test plan development and root cause failure analysis.

Preferred requirements:

• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Desirable
• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.  Desirable
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistical), Desirable
• Stability, Biocompatibility, Sterilization, Ship Testing Knowledge, Desirable

Other Skills:

• Computer literate and experience with PCs, networks, and applications
• DFSS / Lean Green Belt or Black Belt Desirable 
• Familiar with DMAIC or DMADV(DFSS) methodologies Desirable
• Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable
• Travel will be required as part of the job with an estimate of 5-10% travel requirements, this position will be based out of Athlone with potential for world wide interfaces/support required.