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:
1. Develop and maintain documentation in compliance with FDA, ISO, MDR requirements
2. Actively participate in the Documentation control process
3. Review / Approve / Release final product documentation
4. Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
5. Participate / Lead Risk Analysis initiatives e.g. FMEA
6. Initiate / Approve Temporary Deviations
7. Initiate / Support implementation of effective Corrective / Preventive Actions
8. Support the Environmental monitoring process
9. Represent QA as part of the Material Review Board
10. Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
11. Initiate / Approve Engineering Change notices
12. Process Customer Complaints and manage customer replies
13. Support Notified Body / Regulatory Agency / Customer Audits
14. Perform Internal Audits
15. Collate and trend Key performance indicator data on a monthly basis
16. Actively participate in Management Review & Compliance meetings
17. Support a cross functional Production team to meet common goals
18. 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