Design Quality Engineer (12 mth contract)
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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.
