Location: Midlands

Industry Sector: Medical Device

Position Code: 12011

We are currently recruiting a Quality Manager with group responsibilities for our client in the Midlands. The successful candidate will be responsible for the management, direction and coordination of all quality and regulatory activities and in addition will ensure that the highest quality standards are harmonized across the Group’s locations.

RESPONSIBILITIES INCLUDE:

• Ensure that all products manufactured meet required quality specifications.
• Management and development of staff in the Quality department.
• Ensure Customer requirements are achieved by modifying processes / equipment / operating standards as necessary to eliminate defects.
• Liaise with customers, manufacturing, engineering, R&D, and sales & marketing staff on all quality related issues.
• Manage quality metrics and ensure adherence to quality targets.
• Drive key changes and continuous improvement in site Quality systems and procedures.
• Responsible for ensuring adherence to all Company, external and appropriate regulatory requirements (ISO, FDA).
• Ensure that a global system is in place for the Group – common policy and practices across all locations.
• Review international standards and identify relevant GAPS in our quality systems across the entities.
• Provide support to other group companies in relation to QA activities.
• Be a key driver of cGMP practices across the sites.
• Review quality metrics across each site and ensure adherence to quality targets.
• Highlight other strategic QA issues for review by group management

QUALIFICATIONS:

• A third level qualification in a Quality, Engineering or Science Discipline.
• At least 9 years' post-graduation experience in a Quality environment, with at least 5 years' at a management level.
• Candidates from a Medical Device background with  FDA /ISO 9001/2000 or ISO 13485 experience will have a distinct advantage
• Strong planning and organisational ability.
• Knowledge of Statistical Process Control.
• Demonstrated ability to lead, direct and influence people
• Excellent interpersonal and communication skills.

Further Information from:

Micheál Coughlan

E-Mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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