JOB SUMMARY
The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production processes for compliance with implemented process controls.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job-related tasks which may not be specific to this position profile.
Accountabilities include:
* Ensure continued compliance with all Regulatory Standards. This includes: ISO 13485 & MDSAP, ISO 14000, and ensuring continued compliance with Quality Plans and Risk Management Documents.
* Monitor production processes for compliance with implemented process controls to ensure quality products are shipped to customers and provide: Trend analysis of data from the controls, potential improvements for review with engineering based on the trends, areas for improvement to senior management, and review and propose changes to sampling plans based on trend analysis and changes to the system.
* Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
* Support the NCR meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
* Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner: Validations, Change Requests and Document Revisions, Non-Conformance Reports, Internal Audits, Failure Mode Effect Analysis (FMEA), Deviation Requests.
* Project meeting attendance as required.
* Attend and participate in daily cell meetings.
* Preparation of information for KPI and Management Review meetings.
* Be an active member of the Integer New Ross team and work with all employees to develop a world-class lean manufacturing system.
* Comply with the Integer behavioral standards.
SKILLS AND KNOWLEDGE:
* Ability to communicate and work with people inside and outside the department.
* Good communicator (written and oral).
* Ability to train and lead where required.
* Ability to coordinate, plan, and organize in a timely manner.
* Knowledge of Statistical and Quality Improvement methods.
* Good technical report writing skills.
* Rigorous attention to detail.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
* Degree with strong engineering, science, or quantitative content.
* Experience in analysis and reporting using Minitab, Power BI, or equivalent would be an advantage.
* Education requirement can be substituted by strong experience as a quality engineer or technician.
U.S. Applicants: EOE/AA Disability/Veteran
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