Your Job
You will lead the Quality function across our Ireland sites, ensuring robust compliance, strong quality culture, and continuous improvement aligned with both regulatory and customer requirements.
Our Team
Successful candidate will report directly to the EU Director of Quality and will have Managerial responsibilities for over 20 Quality professionals. The Quality Team is a combination of Quality Site Lead, Quality Engineers, Technicians and Inspectors across both facilities.
What You Will Do
- Lead and continuously improve the Quality Management System (QMS) across the Ireland sites
- Provide leadership to the Quality organisation, fostering a high-performing and quality-driven culture
- Ensure compliance with applicable regulatory standards (ISO 13485, FDA and relevant global regulations)
- Act as Management Representative for the QMS across both sites
- Partner cross-functionally to drive operational excellence and long-term quality strategy
- Lead internal, customer, and regulatory audits and ensure effective follow-up on findings
- Drive continuous improvement initiatives across quality systems and processes
- Oversee key quality processes including validation, non-conformance, complaints, and monitoring activities
- Engage with customers, regulatory bodies, and external stakeholders as required
- Develop and coach team members to build capability and support long-term business needs
Who You Are (Basic Qualifications)
- Experience in a quality leadership role within a regulated environment (medical devices, pharmaceutical, or similar)
- Strong working knowledge of quality systems and regulatory frameworks (ISO 13485, FDA or equivalent)
- Proven leadership capability with experience influencing across functions and stakeholders
- Strong analytical mindset with a focus on continuous improvement and value creation
- Excellent communication and relationship-building skills
- Degree in Engineering or a related technical discipline (or equivalent experience)
What Will Put You Ahead
- Experience in multi-site manufacturing environments
- Experience leading regulatory inspections and audits
- Demonstrated ability to drive quality culture and organisational improvement
- Sterilisation knowledge (ETO and GAMMA)
- ERP systems (SAP)
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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