Quality Engineering Manager
On behalf of my client, I am recruiting a Quality Engineering Manager.
The successful candidate will be reporting into the Quality & Regulatory Manager. The Quality Engineering Manager is responsible for the management of the manufacturing quality function across the business and driving compliance and a Continuous Improvement culture.
Must have a third level qualification in Engineering/Quality/Science.
Must have a thorough understanding of Quality Systems / CFRs e.g. ISO 9001 / ISO 13485 / ISO 14001, 21 CFR Part 21 / 820.
Must have a thorough understanding of statistics, SPC, and preferably DOE/Windows studies.
Must have a minimum of 7 years quality management experience preferably in a high-volume FDA regulated environment.
Must be able to work in a team environment.
Must be able to prioritize and organise tasks.
Must have excellent communication skills both oral and written.
Ideally will have experience of Medical Device development form concept to market launch.
Ideally 6 Sigma certified Greenbelt.
Ideally have injection moulding / high speed automation experience.
Essential Duties and Responsibilities:
Establish and develop quality systems, procedures and policies in line with corporate and customer requirements.
Lead continuous improvement initiatives to challenge the quality systems processes with respect to compliance / value add.
Responsible for leading and developing a dedicated team of professionals in order to support the compliant operations within the associated business unit.
Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
Lead and management risk assessments across the business to drive quality improvements.
Drive improvements via data analysis on product and process and drive best practice across the business
Play a key part in transfer projects to ensure flawless transition into Operations.
Develop and sustain the drive towards a business unit culture of walk-in audit readiness.
Play an integral role in planning and managing all activities with respect to quality audits / visits
If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com