Quality Engineer II (Spiddal Galway)

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

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

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.

Roles & Responsibilities

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)
• Initiate / Approve Engineering Change notices
• 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
• Performs 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 an advantage

Quality Certification and Auditor Certification while not mandatory would be an advantage.

U.S. Applicants: EOE/AA Disability/Veteran