Job Details: Quality Systems Specialist

Jervis Street
Dublin 1
Quality Systems Specialist
Orion Group Life Sciences have an exciting opportunity for a Quality
Systems Specialist for our Multinational Medical Devices client based
in the Cork region on an initial **Apply on the website** - month

Job Purpose

Customer Quality member responsible for completing Post Market
Regulatory Affairs activities associated with complaint handling and
MDR submissions. These activities include the submission of Health
Authority Reports and responding to Health Authority Inquiries. This
individual is familiar with the regulations and standards for Medical
Device Reporting.

The Customer Quality Regulatory Specialist works collaboratively with
Quality, Engineering, Manufacturing, Product Development, Regulatory
Affairs and other functional experts internally. Externally, the role
interfaces with Notified Bodies, International Regulatory Authorities,
Health Ministries, Surgeon&#**Apply on the website**;s, and Patients.


* Submission of initial and final vigilance reports in accordance with
MEDDEV 2.**Apply on the website** current revision.

* Co-ordinating timely responses to competent authorities and health
ministry&#**Apply on the website**;s regarding product performance.

* Co-ordinating responses to product performance enquiries from
surgeons, patients and health care providers.

* Support litigation cases and co-ordinate the provision of
performance data to client legal teams

* Partner with client manufacturing sites and design centres to obtain
product performance summaries and data.

* Undertake product performance reviews using available data analysis
tools to respond to enquiries.

* Escalate product performance concerns through the established

* Participate in product risk assessments providing input in order to
evaluate patient risk as required

* Representing client, be pro-active in shaping and influencing
regulatory environment working with Healthcare Industry body groups
and Forums (ABHI, Eucomed etc).

* Attend meetings with health care regulators as required.

* Perform all other work-related duties

* Continuous Improvement Focus

* Additional activities as deemed appropriate by the Complaints


* Self driven and ability to work independently

* Conversant with statistical and data analysis techniques

* Excellent organisational and project management skills, ability to
effectively manage multiple enquiries and projects

* Ability to interpret and analyze information coming from multiple
global sources and multidisciplinary personnel

* Excellent problem solving skills

* Strong collaboration and influencing skills - both internally and

* Excellent communication skills - both verbal and written

* Continuous Improvement Focus

* Ability to travel up to **Apply on the website**%



* A minimum of a Bachelor&#**Apply on the website**;s Degree is

* Regulatory/Quality Systems experience

* 3+ years Medical Devices Industries experience

* Broad experience and knowledge of world-wide quality system
regulations (e.g. FDA **Apply on the website**, **Apply on the
website**; ISO **Apply on the website**, ISO **Apply on the website**)
with a working knowledge of international Health Authority reporting

* Demonstrated proficiency conducting investigations and implementing
corrective and preventive actions

* Ability to work in a cross-functional and matrix environment.

* Actively participates in cross-functional team meetings.

* Requires organizational and critical thinking skills.

* Ability to prioritize and multi task.

* Demonstrates ability to respond to the urgent needs of the team,
with proven track record of meeting deadline.

* Problem solving

* Strong verbal and written communication skills

* Knowledge of basic medical terminology.

* Proficient in MS Office (Word, Excel, Outlook, PowerPoint,

* Ability to interface with technical and non-technical personnel at
all organization levels.


* Master Degree in medical or bio-engineering field

* Conversant with statistical and data analysis techniques

* Project Management experience

* RAC or ASQ certifications a plus

#medicaldevices #medical #device #**Apply on the website**
#multinational #product #implant#quality#systems

For more information on this role, call Dan on (phone number removed)
or email removed) for a completely confidential chat about this role
and other opportunities

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful

We need : English (Good)

Type: Permanent
Category: Others

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