Quality Director

Freudenberg; Spiddal; On-site; EUR 110,000 - 170,000; Full time

Job summary

Freudenberg Medical Ireland Ltd. in Spiddal, Ireland seeks a strategic Head of Quality and Regulatory Management to lead all quality systems and regulatory affairs across the site.

You will ensure ISO13485 and FDA compliance, drive continuous improvement, mentor the QA team, and partner with customers and product introductions to ensure flawless launches. You will develop annual operating plans, implement metrics, manage supplier quality, and align quality strategies with the global Freudenberg

Qualifications

• Bachelor’s degree in Science, Engineering, Manufacturing or related field.
• 10+ years of progressive experience in quality and regulatory in a medical devices environment, with 5+ years in leadership.
• In-depth knowledge of ISO13485 and FDA regulatory requirements.
• Experience using SAP ERP and proficiency in Microsoft Office Suite.
• LEAN and Six Sigma knowledge desirable.

Responsibilities

• Provide strategic direction and leadership for Quality and Regulatory Management.
• Ensure compliance with ISO13485, FDA and global requirements.
• Develop annual operating plans for the quality function aligned with the business AOP.
• Lead supplier quality program and cross-functional collaboration.
• Ensure effective QMS implementation and drive continuous improvement.

Skills

Strategic direction

Leadership

Quality management

Regulatory management

Cross-functional collaboration

Continuous improvement

Education

Bachelor’s degree in Science, Engineering, Manufacturing or related field

Tools

SAP ERP

Microsoft Office

Job description

Working at Freudenberg: We will wow your world!

Responsibilities

Provide strategic direction, leadership and expertise in all aspects of Quality and Regulatory Management. Contribute to the achievement of the overall objectives of the company. Ensure effective execution of quality and regulatory organisational strategies and policies. Develop and achieve annual operating plans for the quality function, aligned with the business AOP. Ensure that quality strategies are aligned with the wider Freudenberg Medical organisation. Ensure that an effective and efficient quality management system, appropriate to the activities at the company, is implemented and maintained. Ensure compliance with all relevant quality and regulatory affairs requirements, including ISO13485, FDA, global Freudenberg Medical Quality System requirements and other appropriate standards. Implement appropriate metrics to ensure that the quality system is efficient, effective and utilised in a proactive manner to deliver competitive advantage. To deliver on all budget (AOP) targets within the scope of quality and regulatory systems. Work effectively with others to ensure that the quality function is both supportive and independent. Manage resources and foster cross-functional teamwork to allow for Operational Excellence targets and Policy Deployment goals to be achieved. Ensure that the Quality team has the required capabilities and competencies. Responsible for the professional development of the Quality team. Support the Talent Management process to continuously improve performance and develop personnel skills and behaviours. Accountable for Management Reviews – provide management with objective evaluation of overall quality and regulatory affairs performance and provide guidance for implementation of improvements. Provide leadership to ensure the flawless launch of new products and processes into production. Partner with customers and new product introduction teams in the development and introduction of new products and processes into manufacturing. Ensure that all product and services delivered by the company adhere to the various quality standards expected by our customers and the industry generally. Partner with customers to pro-actively identify and resolve quality issues and ensure products are manufactured in compliance with agreed specifications. Lead the supplier quality program, ensuring best practice supplier quality assurance approaches are implemented. Work with suppliers on quality related issues. Ensure all dealings are professional and good relationships are maintained at all times. Educate all staff members on Quality Systems regulations and the impact of the regulations on their roles and responsibilities to foster ownership and ensure compliance with quality system procedures and regulations. Fulfil the role of management representative for the Quality Management system. Provide leadership to ensure compliance with the requirements of all applicable safety and environmental agencies, including Freudenberg’s Health, Safety, and Environmental Management System (HS&E) requirements. Actively participate in continuous improvement initiatives, initiation, and implementation. Lead quality related projects ensuring that they are delivered on time and within budget.

Qualifications

• Bachelor’s degree in Science, Engineering, Manufacturing or related field.
• Thorough knowledge of medical devices quality systems (ISO13485/FDA).
• Knowledge of LEAN and Six Sigma methodologies is desirable.
• A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
• Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
• Experience using SAP ERP software and Proficient in Microsoft Office Suite.
• Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

Equal Opportunity Employment

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.

Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.