At a Glance
- Tasks: Support quality and safety processes across the EMEA region in a dynamic healthcare environment.
- Company: Join DePuy Synthes, a leader in medical devices with a commitment to patient safety.
- Benefits: Inclusive workplace, opportunities for growth, and a chance to make a real impact.
- Other info: Collaborative culture with opportunities for professional development and limited travel.
- Why this job: Be part of a team that ensures compliance and enhances patient safety in healthcare.
- Qualifications: Bachelor’s degree in a relevant field and experience in quality or regulatory roles.
The predicted salary is between 35000 - 45000 £ per year.
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
- Bachelor’s degree required in a scientific, engineering, healthcare, or related discipline.
- Advanced degree in Quality, Regulatory, Life Sciences, or a related field preferred.
- 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 Qualifications
- 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 and Travel
- Proficiency in English required; additional EMEA language skills are a plus.
- 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.
We provide an inclusive work environment where each person is considered as an individual. We respect the diversity and dignity of our employees and recognize their merit.
Transportation Commercial Quality Specialist employer: 8722-DePuy International Limited Legal Entity
DePuy Synthes is an exceptional employer that prioritises employee growth and development within a collaborative and inclusive work culture. Located in Leeds, West Yorkshire, our team enjoys access to continuous improvement initiatives and cross-functional partnerships that enhance professional skills while ensuring compliance and patient safety in the medical device industry. With a commitment to diversity and respect for individual merit, we offer a rewarding environment for those seeking meaningful careers in quality and regulatory affairs.
Contact Details:
8722-DePuy International Limited Legal Entity Recruitment Team
