Quality engineer
Test Triangle
cork, CO, ie
2d ago

Job Purpose and primary objectives :

Work as an Engineer / Consultant in the TCS team

delivering best in class solutions and services to our


The job holder will lead the QA element of process /

technological improvements, new product introduction

and product transfers in conjunction with local Quality,

Operations and R&D personnel ensuring timely

communication to all stake holders to effect successful

project completion.

Key responsibilities (please specify if the position is

an individual one or part of a team) :

1. Represent Quality as part of a cross

functional team to ensure delivery of

projects (NPI’s and Technology) into

production with the highest level of quality,

compliance, and adherence to timelines

2. Compile and execute validation protocols

for new product / processes and software.

Ensure correct implementation as per

standard validation procedures. Re-validate

as required due to engineering change,

deviation analysis or upgrade in systems

and material.

3. Use of statistical analysis as part of

validation activity and defining subsequent

inspection and controls in production

4. Develop and utilise DFMEA / PFMEA and

other QA risk analysis techniques in order

to minimise potential risk during

development / implementation activity.

5. Liase with R & D to ensure Critical to

Quality Characteristics are agreed and

documented for all New Product


6. Lead Design for Inspection activities for all

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New Product Introduction to ensure latest

technology is available to reduce Human


7. Lead QA input to Design for Manufacture

activities on site.

8. Ensure daily and project compliance with

all Documented Quality systems i.e. FDA

QSR’s and ISO 13485 / 9001 requirements

etc. during all day to day

9. Provide technical assistance to carry out

problem analysis / complaint investigation

as required and define through negotiation

effective corrective actions.

10. Assist in problem solving for new products

and established production process

enabling reduction in compliance risks,

scrap and reprocessing.

11. Assist in the development, review and

approve product, gauge, tooling and

fixturing drawings.

12. Maintain a good level of house-keeping in

designated areas and observe all Health

and Safety at work requirements.



Supervisory / Managerial responsibilities (please

specify if the position will have persons reporting to

it) :

The candidate will not have direct reportees. However,

as part of the TCS team onsite, he / she will be expected

to participate in business discussions

Other responsibilities Budgets, targets, equipment

etc (please specify) : N / A

Key Skills / Knowledge : 1. Ability to manage multiple assignments or

projects with sound analytical,

troubleshooting, and problem solving skills.

2. Flexible work ethic.

3. Strong influencing skills.

4. Excellent communication skills (written and


5. Problem Solving skills to assist in

maintaining project progress and on design


6. Decision Making required to make

decisions on technical issues.

7. Degree of responsibility must be capable

of taking direction and taking responsibility

and ownership for systems.

8. Excellent planning & organization skills.

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9. Extent of confidentiality - discretion is

essential in view of contact with outside

parties, product development strategies,

regulatory and sales information.

10. Continuous Improvement Focus

Experience required : 1. A degree level or similar qualification in

mechanical or industrial engineering is


2. Basic experience in a quality role within a

regulated industry.

3. Proven ability to successfully introduce new

product development in the Medical Device


4. Proven knowledge and ability regarding

product verification and process validations.

5. Proven knowledge of FDA and MDD GMP

requirements regarding medical Devices.

6. Proven experience and training in Mechanical

Engineering processes

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