|Job Title:||Quality Systems Specialist|
|Contact Name:||Sharon McDonogh|
|Job Published:||27 days ago|
Snr Quality Systems Specialist
Dedicated to excellence in the manufacture of high quality components and assemblies. A very well-established manufacturer with over 30 years’ experience within its sector is currently looking to appoint a Senior Quality Systems Specialist. With an enviable reputation as being one of the most innovative suppliers in Europe, supplying into numerous industries including Automotive, Electronics, Aerospace, Medical and Telecommunications.
This position will deputise for the Quality Manager when absent from site, which includes responsibility as quality management systems representative and leadership for the RAQA department, this opportunity comes with the following responsibilities:
· Assisting in the management, maintenance, improvement, implementation and effectiveness of the Quality System, which includes: Corrective and Preventive Action (CAPA) System, Quality Audits, Risk Management, Quality Systems Training, Management Review, Material Controls, including control of nonconforming material, Records, Documents, and Change control, Supplier Management.
· Control of documents required by quality/regulatory, health & safety and environmental regulations and standards.
· Compliance with Health & Safety and Environmental procedures along with the QMS with all relevant regulatory requirements.
· Products compliance with customer and regulatory requirements and the support and development of systems for the identification, analysis, correction, and prevention of quality issues.
· Participate/assist and lead during FDA, Notified Body or Customer audits/inspections and to assist in drafting responses to external audits/inspections and to coordinate the complaint and internal audit processes.
· Assist in staff training and development.
· Escalate risks and compliance/regulatory.
· Provide support to the QA/RA team on documentation/record keeping issues
· Lead key projects for improvement the quality system and other critical business projects and to participate in continuous improvement activities
• Bachelors' degree preferably in Engineering, Sciences or Business
Comprehensive knowledge of Quality Systems standards and regulations included:
• 21CFR 820, ISO 9001, ISO13485 and MDSAP.
• Experience auditing in a FDA regulated industry (Medical).
• Experience auditing high volume manufacturing and transactional processes.
• Experience in a senior quality and/or regulatory position.
• Competent in Microsoft Word, PowerPoint, Visio, Excel or similar software programmes.
The ideal candidate:
You must be motivated, self-directed and able to work with minimal supervision. You will have the ability to undertake duties that are complex, through interaction of QS elements. You will multi-task and prioritize effectively to meet goals and will possess leadership experience along with previous Project Management leadership experience.
Previous experience in high volume plastic moulding and sterile medical device manufacturing would be of benefit and to have had direct dealing with continues improvement campaigns. The ability to deliver results, whilst displaying great leadership ability and responding to change whilst upholding a team mentality. To be creative when problem solving and confident decision-making ability would also be advantageous.
In return, you will receive an extremely competitive salary along with an attractive benefits package.
For further details, please contact Sharon McDonough at Morgan Ryder Associates