By living according to a common set of values, we create a culture that unifies and positions Integer for long-term success.
Our values are embedded in everything we do.
Culture
We focus on customer success through collaboration and innovation.
Innovation
We create better solutions together with our team members.
Collaboration
We work together to achieve quality results.
Inclusion
We interact with others respectfully and promote candor within the company.
Candor
We communicate openly and honestly with each other.
Integrity
We do things right and maintain high standards across the company.
Quality Engineer II Position Overview
The Quality Engineer II role requires an experienced 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 standards across the company.
This position will support manufacturing in an ISO Class 8 cleanroom environment.
The Quality Engineer II will report to the Quality Supervisor and be responsible for various tasks.
Key Responsibilities:
* Develop and maintain documentation in compliance with FDA, ISO, and MDR requirements.
* Participate in the documentation control process.
* Review, approve, and release final product documentation.
* Initiate and approve non-conformance reports and lead root cause analysis investigations.
* Participate in risk analysis initiatives, such as FMEA.
* Initiate and approve temporary deviations.
* Support the implementation of effective corrective and preventive actions.
* Support the environmental monitoring process.
* Represent QA as part of the Material Review Board.
* Initiate and approve validation protocols and reports (IQ, OQ, PQ).
* Initiate and approve engineering change notices.
* Process customer complaints and manage customer replies.
* Support notified body, regulatory agency, and customer audits.
* Perform internal audits.
* Collate and trend key performance indicator data on a monthly basis.
* Participate in management review and compliance meetings.
* Support a cross-functional production team to meet common goals.
* Perform other related duties as assigned.
Requirements:
A degree in manufacturing engineering, quality engineering, life science, or a related field, and a minimum of 3 years of experience working as a quality engineer within the medical device industry.
The ideal candidate must be highly motivated with excellent communication skills and a proven ability to work as part of a team.
Experience with lean manufacturing tools and techniques is an advantage.
Quality certification and auditor certification would be an advantage but are not mandatory.
We are an equal opportunity employer and welcome applicants from diverse backgrounds.