Exciting Opportunity for a Quality Manager, required by CareerWise Recruitment for our North West based client. This is a brilliant opportunity to progress within a medical device company.
* Facilitate investigation, trouble shooting and reporting on system failures and product defects.
* Ensuring release of product in accordance with approved procedures.
* Final disposition of non-conforming product including MRB co-ordination.
* Interact routinely with all functional areas as well as with customers, field sales, division/group/corporate management, and suppliers.
*Maintenance of the plants ISO 13485:2003 / FDA 21 CFR Part 820 compliant Quality System.
* Management of the Quality Assurance Function and reporting on the effectiveness of the Quality Management System to the senior management team.
* Management of the plant Corrective and Preventive Action systems.
* Ensuring that products manufactured meet requirements of end users, of regulatory authorities and of the company.
* Auditing (with other management personnel) of the quality system.
* Ensuring that all plant personnel are fully aware of quality requirements.
* Review of customer complaints and device vigilance assessment.
* Product withdrawal or recall from the marketplace where necessary.
* Management of the company's validation programme.
* Control of plant environmental (hygiene and microbiological) programme.
* Approval and maintenance of plant housekeeping procedures.
* Deputising for the General Manager in his/her absence.
* Complete internal and vendor/contractor audits to monitor the effectiveness of the quality system and check the level of compliance to the quality system.
* Maintaining the plants calibration programmes for test and inspection equipment.
* Change control, deviation and the risk assessment activities associated with these activities
*The Quality Manager should have a 3-5 years People Management experience, and a proven track record in motivating people and performance management.
*Degree qualified as a minimum in Quality/Engineering/Science discipline
*Experience in the medical device industry and excellent knowledge of ISO 13485:2003, FDA 21 CFR Part 820, and MDD 93/42/EEC
*Willingness to travel when required.
Please call Louise Mulligan today for further information on 0949003979 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.