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Quality Manager

Location: Galway
Experience:7-9 Years
Job Type:Permanent
Salary:Not Disclosed
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Quality Manager
Our Client, a global medical device organisation requires a Quality Manager to join their team on a permanent basis. The ideal candidate will have excellent people management experience and experience working within a GMP environment within Medical Devices or Pharmaceuticals.

• Develop and manage a high performance quality engineering and vendor teams
• Create a strong collaborative team working environment with focus on customer needs, product quality and compliance
• Demonstrate commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices and the maintenance of an effective quality system
• Drive continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures
• Lead and demonstrate expertise in the areas of QSR and ISO standards & constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis
• Proactively protect the customer through ensuring that all products are manufactured to the highest standards and under the highest GMP conditions
• Support audits from external regulatory agencies and customers and leads preparation activities in advance of such audits
• Ensures all customer queries and concerns are professionally addressed in a timely manner
• Participates in new product introduction to ensure quality is built into all products early in their life cycle
• Take responsibility to make decisions related to product quality, including the disposition of non-conforming product
• Participate in Customer Complaint investigations for areas under their control and escalates critical issues as appropriate
• Manage and provide guidance and assists in defining, implementing and follow-up of corrective and preventive actions and supplier corrective action reports, ensure that adequate corrective action is put in place by suppliers and monitor effectiveness of same
• Provides best in class root cause analysis & problem solving guidance
• Works cross-functionally to deliver on the site strategic targets and objectives
• Provides direction on Vendor Quality Management strategy and direction for the site
• Lead investigation of component/material quality issues as they arise - works with supply chain, manufacturing and suppliers to resolve issues and to disposition materials
• Works proactively with suppliers to drive improvements in supplier material and service quality
• Assist engineering teams in the development of new supply
• Contributes to the development, maintenance and improvements of corporate supplier management policies and procedures
• Promoting the Quality System within the Supply Base - working with Purchasing, Supplier Quality Engineering, Receiving Inspection and the business units to ensure that components meet our requirements
• Participate in Site & Corporate initiatives

• Bachelors Degree in Science, Engineering or related subject
• 8+ years relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry
• Excellent coaching/mentoring skills
• Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role
• Experience in people management and development
• Strong team building skills with proven abilities in decision making and sound personal judgment
• Good organization and investigation skills are required
• Proven ability to influence
• Excellent “hands-on” technical skills
• Excellent communication skills

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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