Social network you want to login/join with:
Quality Engineer II (Spiddal Galway), Spiddal
Client:
Location:
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
1c7821042045
Job Views:
2
Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success.
We create better solutions.
We create success together.
Inclusion
We always interact with others respectfully.
We are open and honest with one another.
Integrity
We do the right things and do things right.
QUALITY ENGINEER II
The position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company. The position will be supporting manufacturing in an ISO Class 8 cleanroom.
Reporting to the Quality Supervisor, the position will be challenging and will require an ability to work autonomously.
The Quality Engineer shall:
* Develop and maintain documentation in compliance with FDA, ISO, MDR requirements.
* Actively participate in the Documentation control process.
* Review / Approve / Release final product documentation.
* Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations.
* Participate / Lead Risk Analysis initiatives e.g. FMEA.
* Initiate / Approve Temporary Deviations.
* Initiate / Support implementation of effective Corrective / Preventive Actions.
* Support the Environmental monitoring process.
* Represent QA as part of the Material Review Board.
* Initiate / Approve Validation protocols and reports (IQ, OQ, PQ).
* Process Customer Complaints and manage customer replies.
* Support Notified Body / Regulatory Agency / Customer Audits.
* Perform Internal Audits.
* Collate and trend Key performance indicator data on a monthly basis.
* Actively participate in Management Review & Compliance meetings.
* Support a cross functional Production team to meet common goals.
* Perform other related duties, as assigned.
Role Requirements
A degree in Manufacturing Engineering, Quality Engineering, Life Science or related field and a minimum of 3 years experience of working as a Quality Engineer within the Medical Device Industry.
Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
Experience of using Lean Manufacturing Tools and Techniques is an advantage.
Quality Certification and Auditor Certification, while not mandatory, would be an advantage.
U.S. Applicants: EOE/AA Disability/Veteran
#J-18808-Ljbffr