Quality Manager

Freudenberg Group; Carrick-on-Shannon; On-site; EUR 90,000 - 130,000; Full time

Job summary

Freudenberg Medical Ireland Ltd. in Carrick-on-Shannon is seeking a Quality Manager to lead, develop, and maintain compliant quality systems across the site, ensuring regulatory and customer requirements are met.

You will serve as Management Representative to regulatory bodies, manage audits and responses, act as the primary contact for quality issues, and drive continuous improvement through risk management, SPC, and Lean initiatives while supporting new product development.

Qualifications

• Degree or Masters in Quality Systems, Regulatory Affairs, Biomedical Engineering or similar.
• Minimum of 10 years in Quality Systems compliance within Medical Devices.
• Minimum 3 years of management experience.
• Extensive knowledge of ISO 13485, FDA QMSR and GMP regulations.
• Knowledge of ISO 14001, ISO 45001 and ISO 50001 preferred.
• Lead Auditor qualification preferred.

Responsibilities

• Lead, develop, and manage effective quality systems to meet regulations and site needs.
• Serve as Management Representative for regulatory bodies and management reviews.
• Manage client quality systems audits and responses to audit concerns.
• Act as primary contact for customers on quality issues and field complaints.
• Support lean/continuous improvement and safety initiatives; aid in new product development.

Skills

Quality Systems

Regulatory Affairs

Biomedical Engineering

Leadership

Lean / Continuous Improvement

Education

Master's in Quality Systems / Regulatory Affairs or Biomedical Engineering

Job description

## Quality ManagerApplylocations: Carrick-on-Shannon, Co. Leitrimtime type: Full timeposted on: Posted Todayjob requisition id: R\_00105175**Working at Freudenberg: We will wow your world!**# Responsibilities:Responsible for leading, development, and management of effective and compliant quality systems and work closely with various cross functional members of site to ensure all requirements are described and meet the needs of regulations and functional excellence. Serve as Management Representative responsible for representing site to all regulatory bodies including registered notified bodies and ensuring management review activities are conduct per regulations. Manage all client quality systems audits and ensure timely response to any audit concerns. Act as the primary contact for customers regarding quality related issues/activities. Ensure all field complaints are response per regulatory requirements. Participate in strategic planning activities to ensure that all quality related requirements are considered when establishing strategic goals and objectives. Participate in new product/project development to ensure quality requirements are established. Work directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, improve yield and product quality, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Ensure that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics. Participate and support lean/continuous improvement initiatives and safety initiatives. Ensure the quality activities are planned; resources allocated; priorities established and activities executed to meet goals, Working within the people management systems in the Company to develop others (performance management, rewards and selection process); and Creating an energizing work environment that supports the Company’s high performance culture while ensuring and efficient and flexible organization.# Qualifications:* Degree / Masters Qualified –preferably in Quality Systems, RegulatoryAffairs, Biomedical Engineering or similar* Minimum of 10 years previous experience involved in Quality Systems compliance within the Medical Devices sector* Minimum 3 years management experience* Extensive knowledge and understanding of the ISO 13485, FDA QMSR and GMP regulations* Knowledge and understanding of ISO 14001, ISO 45001 and ISO 50001.* Lead Auditor qualified preferred The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.Freudenberg Medical Ireland Ltd.