Transportation Commercial Quality Specialist

Equal Employment Opportunity

We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Overview

The EMEA CQSS Specialist supports the execution and continuous improvement of regional Commercial Quality and Safety Surveillance (CQSS) activities across the EMEA region. This role plays a critical part in ensuring compliance with applicable quality system requirements, supporting post market surveillance and vigilance processes, and partnering cross functionally to maintain patient safety and regulatory readiness.

Key Responsibilities

• Support EMEA CQSS activities, including post market surveillance, quality system compliance, and safety reporting processes in alignment with global and regional requirements.
• Assist in the execution and maintenance of quality system documentation, including procedures, work instructions, and records related to CQSS activities.
• Participate in complaint handling, vigilance, and trend analysis activities to support identification and escalation of quality and safety issues.
• Support internal and external audits, inspections, and regulatory inquiries by preparing documentation and responding to information requests.
• Collaborate with cross functional partners (e.g., Regulatory Affairs, Medical Safety, Operations) to support timely investigation and resolution of quality and compliance issues.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance CQSS processes, tools, and reporting.
• Maintain accurate tracking and reporting of CQSS metrics to support management review and regulatory compliance.

Qualifications

Education: Bachelor's degree required in a scientific, engineering, healthcare, or related discipline. Advanced degree in Quality, Regulatory, Life Sciences, or a related field preferred.

Experience and Skills: Typically requires 2-4 years of relevant work experience in Quality, Compliance, Regulatory Affairs, or a related function within a regulated industry (e.g., medical devices, pharmaceuticals). Working knowledge of quality systems and compliance requirements (e.g., ISO 13485, post market surveillance, vigilance). Experience supporting investigations, documentation, and quality records in accordance with established procedures. Strong attention to detail with the ability to manage multiple priorities in a regulated environment.

Preferred: Experience supporting EMEA based quality, vigilance, or regulatory activities within the medical device industry. Familiarity with EU MDR/IVDR post market surveillance and safety reporting requirements. Experience participating in audits or health authority inspections. Proficiency with quality systems, databases, and reporting tools. Effective written and verbal communication skills, with the ability to collaborate across functions and regions.

Languages: Proficiency in English required; additional EMEA language skills are a plus.

Travel: Limited regional travel may be required (generally up to 10%).

Certifications: Quality or Regulatory certifications (e.g., ASQ, ISO Lead Auditor) preferred but not required.

Benefits and Compensation

Anticipated base pay range: €52,400.00 - €82,915.00.

In addition to base pay, benefits include annual bonus with set target (% of pay), vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well being reimbursement, financial, physical and mental health programs, service anniversary and recognition awards, and participation in various insurance plans.

Locations

Ringaskiddy, Cork, Ireland; Umkirch, Germany; Loughbeg, Ringaskiddy; Zug, Switzerland.