Transportation Commercial Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. 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 Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Leeds, West Yorkshire, United Kingdom, Ringaskiddy, Cork, Ireland, Tallaght, Dublin, Ireland

Job Description:

DePuy Synthes is recruiting for a(n) EMEA CQSS Specialist,   located   in L St Anthony's Road, Leeds, UK Alternate Hybrid locations may be considered at Umkirch, Germany, Loughbeg, Ringaskiddy, Zug, Switzerland

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Loughbeg, Ringaskiddy Ireland and Umkirch, Germany  - Requisition Number: R-082530

Zug, Switzerland - Requisition Number: R-082534

Johnson & Johnson announced plans to separate our Orthopedics business to   establish   a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is   anticipated   to be completed within 18 to   24 months , subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be   required , regulatory approvals and other customary conditions and approvals. Should you accept this position, it is   anticipated   that, following conclusion of the transaction, you would be an employee of DePuy   Synthes   and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at   an appropriate time   and subject to any necessary consultation processes.

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. This is an opportunity to contribute directly to product quality, regulatory compliance, and patient outcomes within a leading   orthopedics   organization.

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

Required:

- 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.

Other:

- 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 .

For more information on how we support the whole health of our employees throughout their wellness,   career   and life journey, please visit   www.careers.jnj.com .

Required Skills:

Preferred Skills:
Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment