Job Details
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| Quality Manager - Post Production | | |
| Location: | | Europe (Non UK) | | |
Description
This is a great opportunity to join our client's organisation as a Senior Leader in Quality. This is a unique leadership role in a varied department with responsibility for all pre and post production Quality Assurance decisions.
Job Purpose
Demonstrates a commitment to Quality (patient safety and product quality) through their daily execution of sound quality practices, decision making and the maintenance of an effective quality system.
Understands and complies with all the regulations governing the quality systems from medical device and combination products.
Provides leadership to a team of 50 Quality personnel in the Pre and Post Quality Department.
Key Responsibilities
Areas of responsibility include:
Product release including quality support for shipping and warehouse
QA Operations Laboratory (mechanical testing)
Calibration services for the site
Supplier Quality Assurance - all vendors for Galway site
Receiving and Inspection Quality Assurance
The above functions are Galway site based, in addition the role will involve working with Corporate Quality groups in each area of expertise.
Develops and manages a high performance quality engineering team with focus on customer needs, compliance, product quality, and risk mitigation.
· Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
· Participates in Customer Complaints investigation for areas under their control
Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within ones own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Site QA Director as the final arbitrator on critical quality decisions.
Develops, directs and executes plans for major segments of complex projects from a quality perspective.
Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where possible.
Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
Is a champion of continuous improvement with particular focus on product quality through six sigma initiatives.
Is an effective people manager resulting in a motivated high performance team. Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
Qualifications
A graduate of Engineering, Sciences or equivalent (ideally chemical engineering) with a minimum of 5 years people management experience in a healthcare or similar environment. | | |
Reference
IJ-MK/31520/IJP | | |
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