Our client, a medical device company in Galway are currently looking to recruit a Quality Manager for their site.
- Develops and manages a high performance quality engineering and vendor teams. Creates a strong collaborative team working environment with focus on customer needs, product quality and compliance
- Demonstrates 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.
- Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
- Leads and demonstrates expertise in the areas of QSR and ISO standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
- Proactively protects 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.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Participates in Customer Complaint investigations for areas under their control and escalates critical issues as appropriate.
- Manages and provides guidance and/or 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.
- Assists 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.
- Percent Travel Required:15
- 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.
For further information on this Quality Manager role in Galway please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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