Transportation Commercial Quality Specialist

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

Job Locations

Ringaskiddy, Cork, Ireland; Umkirch, Germany

Job Description

DePuy Synthes is recruiting for a EMEA CQSS Specialist, located in LSt Anthony's Road, Leeds, UK. Alternate hybrid locations may be considered at Umkirch, Germany, Loughbeg, Ringaskiddy, Zug, Switzerland.

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, 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.

Salary and Benefits

The anticipated base pay range for this position is €52,400.00 - €82,915.00.

In addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade/location, where the actual amount is based on the employees' and company's performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.