Quality Engineer

Responsibilities & Duties
· Support quality improvement initiatives such as process and product
characterizations that lead to continuous / cost improvements.
· Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques
and/or other improvement tools and programs.
· Conduct benchmarking to develop more effective methods for improving quality
· Supports the development of quality engineering and quality compliance with the
right skill sets for new product introductions, and product life cycle management.
Compliance/Regulatory
· Review/analyze whether current product and processes (including actions or
decisions conducted) are in compliance to standards such as the QSRs, ISO 13485,
etc.
· Champions compliance to applicable Global Regulations and standards (e.g. QSRs,
ISO, EN and Medical Device Directive (MDD) requirements) including providing
support during internal and external audits.
· Conduct periodic line audits to assess for production controls such as lot
segregation. Review results of area audits to ensure that corrective and preventive
actions are adequate.
New Product/Process Introduction
· Partners with R&D and other cross functional partners to ensure the proper
application of design controls, risk management and the investigation/correction of
design failures/challenges.
· Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards
· Lead and maintain Material Review Board.
· Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as
appropriate.

Qualifications
· A minimum of a Bachelors Degree, preferably in Engineering or related technical
field. Generally requires 4-6 years related experience.
· Experience working in both an FDA and European regulatory environment is
preferred.
· This position will require relevant experience working in manufacturing/operations.
· In-depth knowledge of product/process Risk Management (FDA and ISO standards)
is required.
· Experience with a proven track record of implementing appropriate risk mitigation.

· Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs,
Reliability, etc.
· Strong knowledge of statistical software packages is preferred with the ability to
preview, graph and analyze data and be able to present data that facilitates/drives
decision making.
· The ability to perform “hands on” troubleshooting and problem solving is required.
The ability to think on the feet and providing sound judgment is highly desired.
· Good technical understanding of manufacturing equipment and processes is
required.
· Understanding of the NPI (New Product Introduction) process and Process Validation
expertise is preferred.
· A thorough understanding of GMP/ISO regulations and validation regulations is
preferred.

Interested candidates should submit an updated CV.

Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to william.cunnage@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***