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Job Description
Quality Engineer sought to maintain and improve quality systems, ensuring compliance with regulatory standards and monitoring production processes for quality product shipment.
Integer, a company that values a unified culture, is seeking a Quality Engineer to join their team. 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.
Our values are embedded in everything we do. We focus on our customers' success, create better solutions, and work together to achieve success. We always interact with others respectfully, are open and honest with one another, and do the right things and do things right.
Responsibilities
- Ensure continued compliance with all Regulatory Standards, including ISO 13485 & MDSAP, ISO 14000, and Quality Plans and Risk Management Documents.
- Monitor production process for compliance to implemented process controls, providing trend analysis of data from the controls, potential improvements for review with engineering, and areas for Improvement to senior management.
- Ensure that in your absence, your area of responsibility is covered, and 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, including Validations, Change Requests and Document Revisions, Non Conformance Reports, Internal Audits, Failure Mode Effect Analysis (FMEA), and Deviation Requests, are approved in an appropriate and timely manner.
- Attend and participate in daily cell meetings, project meetings, 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 behavioural standards.
Requirements
- 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 co-ordinate, plan and organise in a timely manner.
- Knowledge of Statistical and Quality Improvement methods.
- Good technical report writing skills.
- Rigorous attention to detail.
Education and Experience
- 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 quality engineer or technician.