Position Summary

The Commercial Quality Specialist plays a critical role in ensuring compliant, efficient, and market-facing quality operations across the EMEA region. This position bridges operational execution and strategic quality initiatives, focusing on the management of Field Actions, Supplier Quality, and continuous improvement of the Commercial Quality System. The role does not include direct reports but requires strong cross-functional collaboration and influence.

Key Responsibilities

Field Actions Management

• Lead the execution and coordination of Field Actions across EMEA in alignment with Abiomed SOPs and regulatory requirements.

• Ensure timely communication and documentation of Field Actions with internal stakeholders and external partners.

• Monitor effectiveness checks and closure activities to ensure regulatory compliance and patient safety.

Supplier Quality Oversight

• Support supplier qualification, monitoring, and performance evaluation activities.

• Collaborate with Procurement and Supplier Quality teams to address non-conformances and drive corrective actions.

• Contribute to supplier audits and ensure alignment with J&J standards and applicable regulations.

Commercial Quality System Improvement

• Identify and implement process improvements within the Commercial Quality System to enhance efficiency and compliance.

• Support change control, CAPA, and risk management activities related to distribution, transportation, and customer service.

• Participate in the development and refinement of SOPs and quality documentation.

Market-Facing Quality Support

• Act as a quality representative for commercial operations, ensuring that market needs and regulatory expectations are met.

• Collaborate with Distribution, Customer Service, and Regulatory Affairs to resolve quality issues impacting customers.

• Support internal and external inspections and audits as needed.

Training & Development

• Maintain up-to-date knowledge of applicable regulations, J&J policies, and Abiomed procedures.

• Engage in continuous professional development and contribute to knowledge sharing across the team.

Qualifications

Education

• Required: Bachelor’s degree in science, engineering, or a related discipline.

• Preferred: Master’s degree in business, quality management, or regulatory affairs.

Experience

• Minimum 3–5 years of experience in quality, regulatory, or compliance roles within medical device or pharmaceutical industries.

• Proven experience in Field Actions, supplier quality, and quality system improvement.

• Familiarity with SAP and Quality IT Systems is preferred.

• Experience working in multi-country, multicultural environments and with healthcare regulatory bodies (e.g., FDA, MHRA, TGA).

Skills

• Strong analytical and strategic thinking with the ability to manage both tactical and high-level tasks.

• Excellent collaboration and influence management skills across functions and geographies.

• Ability to build consensus and drive decisions without direct authority.