By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to Integer, and positions it for long-term success.
At Integer, our values are embedded in everything we do.
Our Core Values
* 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
Reporting Structure
The Quality Systems Technician will report to the Quality Supervisor.
Role
As a Quality Systems Technician, you will actively support quality systems and compliance activities, including review and maintenance of documents, records, and data, as well as support for audit preparation and execution activities, non-conformance reports, corrections, corrective actions, and process improvements within your area of responsibility.
Responsibilities & Duties
* Compliance with applicable regulatory standards and current GMP procedures and practices.
* Maintain QS documentation and records in a compliant state.
* Support and maintain document control processes.
* Support and participate in audits (internal and external) and follow-up activities.
* Complete administrative reviews for Complaint/Manufacturing Investigations.
* Initiate and process Engineering Change Notices for document updates.
* Support and actively participate in Supplier Management Process activities.
* Participate in Non-Conformance Reports, Corrections, Corrective & Preventive Actions within your area of responsibility.
* Participate in Continuous Process Improvement Initiatives.
* Evaluate potential deficiencies to ensure timely resolution.
* Collect, trend, and present Key Performance Indicators and Quality data to support communications and management review.
* Participate in training events to continuously develop and maintain competencies.
* Respond to customer requests outside of standard operating procedures.
* Support quality system compliance activities, including reviewing standards and following up to ensure satisfactory closure of identified gaps.
* Train personnel on completion of responsibilities associated with Quality Systems and Document Control.
* Provide support for Document Control Activities and Personnel.
* Perform other related duties assigned by Quality Leadership.
Education & Experience
A minimum of 2 years' experience working within the Medical Device/Pharmaceutical Industry is required.
Previous work experience within QS/QA/QC environments is preferred.
Familiarity with Medical Device Regulatory Requirements (e.g. ISO13485, FDA QSR 21CFR Part 820).
Bachelor's or Master's Degree in Manufacturing/Quality Engineering/Life Sciences is preferred.
Capabilities & Abilities
* Knowledge and adherence to Quality Systems.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
* Experience with Electronic QMS Systems (SharePoint, Reliance, etc).
* Ability to work independently and as part of a team.
* Excellent documentation skills with attention to detail.
* Logical approach to work practices and processes.
* Strong written and verbal communication skills.
* Basic understanding of statistical techniques.
* Ability to handle challenging situations.
* Capacity to influence change.
* Highly motivated.
* Self-aware, optimistic, and empathetic.