Our client a medical device company in Galway is looking to hire a
Quality Systems Engineer for their site on a permanent basis.
The role is within Quality systems, with a responsibilities for
Quality Management, Internal and External Audits
Key Responsibilities
* Will act as an expert resource in external regulations and standards
requirement - is viewed as a leader in the areas of ISO/MDD quality
systems standards, constantly promoting awareness of best industry
practices.
* Leads/manages internal audits of the Quality System that evaluate
the adequacy and compliance of systems, and identify areas of
potential noncompliance or improvements.
* Serves as a member of the audit team, participating in audits of
varying complexity. Audit assignments are technical and complex in
nature.
* Performs timely and adequate effectiveness checks and monitors
corrective action progress for audit non-conformities.
* Leads/manages inspection activities of the Quality System related to
regulatory agencies or notified bodies.
* To provide assistance and support to the engineering and operational
functions on quality system requirements.
* Champions continuous improvement and innovation from a quality
system perspective.
* Collect and analyze business/quality system process data from
different parts of the company.
* Applies sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues.
* May assist with development and maintenance of department metrics
Qualifications/ Experience
* Decision making ability coupled with the ability to work on
one&#**Apply on the website**;s own initiative and with minimum
supervision is required.
* Good interpersonal skills and organisational skills.
* Excellent attention to detail.
* NFQ Level 8 or above in Science or Engineering Discipline.
* 5+ years experience in a similar role
* People management experience Senior Quality Systems Engineer - Galway
Our client a medical device company in Galway is looking to hire a
Quality Systems Engineer for their site on a permanent basis.
The role is within Quality systems, with a responsibilities for
Quality Management, Internal and External Audits
Key Responsibilities
* Will act as an expert resource in external regulations and standards
requirement - is viewed as a leader in the areas of ISO/MDD quality
systems standards, constantly promoting awareness of best industry
practices.
* Leads/manages internal audits of the Quality System that evaluate
the adequacy and compliance of systems, and identify areas of
potential noncompliance or improvements.
* Serves as a member of the audit team, participating in audits of
varying complexity. Audit assignments are technical and complex in
nature.
* Performs timely and adequate effectiveness checks and monitors
corrective action progress for audit non-conformities.
* Leads/manages inspection activities of the Quality System related to
regulatory agencies or notified bodies.
* To provide assistance and support to the engineering and operational
functions on quality system requirements.
* Champions continuous improvement and innovation from a quality
system perspective.
* Collect and analyze business/quality system process data from
different parts of the company.
* Applies sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues.
* May assist with development and maintenance of department metrics
Qualifications/ Experience
* Decision making ability coupled with the ability to work on
one&#**Apply on the website**;s own initiative and with minimum
supervision is required.
* Good interpersonal skills and organisational skills.
* Excellent attention to detail.
* NFQ Level 8 or above in Science or Engineering Discipline.
* 5+ years experience in a similar role
* People management experience
We need : English (Good)
Type: Permanent
Payment:
Category: Others
