Our client a SME is recruiting for a Quality Manager to join their team in Clare. This is a permanent role and would be commutable from Galway, Limerick and surrounding areas of Clare.
- Ensures the processes needed for the Quality Management system are established, implemented and
- Reports to management on the performance of the QMS and any need for improvement.
- Compile and analyse operational, test and validation data to establish technical specifications and
performance standards for newly designed or modified products and processes.
- Take 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.
- Manage Quality System procedures and controls ensuring that performance and product quality
conforms to established company and regulatory standards.
- Develop, implement and monitor annual Quality Objectives for the department & the wider Quality
organisation as required.
- Ensure compliance with safety, regulations, ISO standards, Quality Business Systems and Corporate
- Control budgets and spending and ensure compliance to financial requirements.
- Project manage and schedule key projects and initiatives ensuring timely execution and goal
- Integrate with corporate requirements and promotes synergy/consistency with other sites and
- Assist Managing Director/ Site Operations Manager in developing strategies for the quality function.
- Demonstrates through management style respect for the core values and a commitment to
teamwork and communication.
- Actively participate in short and long range planning including the development of KPI’s.
- Manage the budget and resources of the department to ensure funds and resources are applied to
fulfil the strategic goals of the company.
- Acts as the champion for the customer quality to all employees and builds a culture of customer
awareness and responsiveness at all levels in the organization.
- Promotes awareness of regulatory and customer requirements throughout the organization.
- Presents all aspects of CM’s quality policies and standards to customer/ potential customers while building professional rapport and relationship with them.
- Build external relationships; improve knowledge of regulatory trends and position company to efficiently comply to standards including vendors, service providers etc.
- Coordinate, host and ensure proper follow up to external audits (e.g. Customer Audits and ISO audits).
- Investigating OOS/OOT results and implementing CAPAs as required.
- Oversees CMs risk management system.
- Act as Management Representative & participates in the Management review process of CM and all key partners.
- Develop regulatory strategies and provide strategic regulatory input and support throughout the organisation. Convert strategies to established business practices throughout the organisation.
- Work with the wider Quality function in the company to enforce the Quality System and quality strategy, ensuring that short/long range quality strategy, plans, goals, annual operating plans and budgets are aligned with the business objectives.
- Build internal relationships; improve knowledge of business and relative departments ensuring that quality and compliance is the highest priority.
- Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
- Be recognised as leader of behavioural/GMP and cultural initiatives with strong quality related decision-making skills demonstrated.
- Assign resources and responsibilities. Set direction and identify priorities.
Education & Experience Required:
- Level 8 degree (minimum) in a relevant Engineering/Science discipline
- Experience in Medical Device environment
- 3 years + experience (minimum) in a leadership role within a manufacturing environment
- Experience/training in problem solving and process improvement methodologies
- Excellent analytical and problem-solving skills
- Strong knowledge of quality principles and the ability to apply these methods in a manufacturing environment
For further information on this Quality Manager role in Clare please contact Helga Reeves on 086 8168298 firstname.lastname@example.org
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