Site Quality Director (MedTech)

Location: Limerick, Ireland; onsite manufacturing site with up to 10% travel

Salary: €104,000–€179,515 base pay per year

Company

Johnson & Johnson MedTech develops healthcare and vision care products using biology, technology, and medical innovation.

What you will do

• Lead the site Quality organization and promote regulatory compliance, quality culture, risk-based decision making, and continuous improvement.
• Own the effectiveness of the Quality Management System, including governance, management reviews, performance reporting, and inspection readiness.
• Oversee quality investigations, CAPA, trend analysis, process excellence, statistical methodologies, and quality risk improvement.
• Provide strategic direction as a member of the Site Leadership Team and lead cross-functional quality initiatives.
• Provide oversight for Validation, Quality Assurance/Compliance, CAPA, Complaint Handling, Microbiology, and Quality Control laboratory functions.
• Act as the primary quality representative for inspections and audits, manage resources and budgets, and exercise authority over procedure changes and product or process holds.

Requirements

• Bachelor’s degree in science, engineering, or a related technical field.
• 15+ years of experience in medical device and/or pharmaceutical quality assurance, including at least 10 years in leadership.
• Senior quality management experience in a medical device or pharmaceutical manufacturing company.
• Comprehensive knowledge of process excellence, statistical process control, manufacturing, sterilization, quality assurance, and applied statistics.
• Thorough knowledge of FDA and international regulatory requirements, including 21 CFR 820, ISO 13485, EU MDD/MDR, and applicable global regulations.
• Strong leadership, communication, organizational, problem-solving, strategic thinking, and cross-functional facilitation skills; understanding of AI concepts, responsible AI practices, and effective prompting.

Nice to have

• Advanced degree or postgraduate qualification in Quality, Engineering, Science, or a related discipline.
• Experience with compliance management, GMP, ISO 9001, quality validation, risk assessments, SOPs, succession planning, and developing others.

Culture & Benefits

• Inclusive environment focused on employee dignity, diversity, wellbeing, and career development.
• Competitive compensation with an annual performance bonus.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Wellbeing reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition programs subject to plan and location terms.