Quality Lead

JOB SUMMARY:

Heidelberg Engineering is seeking an experienced, hands-on Quality Lead to lead and own the company's Quality Management System (QMS) within a regulated medical device environment and establish annual management reviews.

The successful candidate will maintain and ensure compliance of site-specific QMS processes aligned with global QM while actively driving continuous improvement, regulatory readiness, and a culture of quality across the organization.

This position offers a unique opportunity to directly influence compliance strategy, operational excellence, and the future growth of the Quality function.

The successful candidate will closely collaborate with the HE Headquarters in Germany and establish a quality reporting.

KEY RESPONSIBILITIES:

Full QMS Ownership (Strategy + Execution)

• Own, maintain, and continuously improve the Quality Management System to ensure regulatory compliance and operational effectiveness.
• Balance strategic oversight with daily hands-on execution of quality activities.
• Identify systemic risks and gaps, implement corrective strategies, and strengthen compliance infrastructure.
• Develop quality objectives aligned with business goals and corporate standards.
• Hands-On Quality Operations.
• Support complaint handling and investigations in coordination with global HQ. Escalate and support MDR/reportability decisions.
• Maintain and administer document control, change management, and training systems.
• Support risk management activities across the product lifecycle.
• Analyze field performance trends and implement preventive and corrective actions.

Regulatory & Audit Leadership

• Serve as the primary on-site liaison during FDA inspections in coordination with global regulatory teams.
• Prepare for, host, and respond to regulatory inspections and external audits.
• Conduct and facilitate Management Review meetings, providing executive-level quality performance reporting.
• Support post-market surveillance, regulatory reporting, corrections, removals, and recall strategy development.

Organizational Influence & Strategic Partnership

• Act as a trusted advisor to senior leadership on regulatory risk, compliance strategy, and quality performance.
• Drive cross-functional accountability for regulatory compliance and continuous improvement.
• Promote a strong quality culture across all departments.

Build scalable systems and processes to support future growth of the Quality function.