Director Quality

QUALITY DIRECTOR

Would you like to work in an international environment where you’ll make a difference every day? At Permobil, we’re looking for game‑changers to join us as we innovate for individuals and develop the world’s most advanced assistive solutions.

Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching. We are committed to continuous improvement and provide market‑leading solutions driven by insights‑based clinical data.

Position Overview

The Quality Director is the senior quality leader for the Progeo (Italy) and Supportec (Netherlands) manufacturing sites, and for product development and design assurance for Progeo. The role is accountable for regulatory compliance, product quality and continuous improvement, leading a robust QMS across the full product lifecycle, including design transfer, change implementation, audit readiness and the compliant adoption of automation and AI‑enabled manufacturing technologies.

As part of the site leadership team, the role partners closely with Product Innovation (R&D) and Operations to ensure efficient, compliant design transfer in an agile environment. The Quality Director also leads audit readiness and regulatory compliance, acting as PRRC and Management Representative in line with ISO 13485, 21 CFR 820, and EU MDR, while driving a strong culture of quality and continuous improvement. This is a hybrid position based in Treviso.

Key Responsibilities

• Lead and ensure an effective, compliant Quality Management System (QMS) aligned with ISO 13485, FDA 21 CFR 820, EU MDR, and global standards; act as Management Representative and EU PRRC.
• Oversee core QMS processes (CAPA, non‑conformance, audits, change control, complaints, validation, risk management) and drive continuous improvement.
• Own quality oversight of design transfer and post‑market design changes, ensuring compliant and efficient implementation into manufacturing.
• Partner with Product Innovation (R&D) and Operations to ensure manufacturability, risk mitigation, validation, and full traceability of design changes.
• Provide quality leadership to manufacturing, including investigations, CAPA, product acceptance, and maintaining validated, controlled processes.
• Ensure compliant implementation and validation of automation, digital systems, and AI‑enabled technologies, with strong data integrity practices.
• Lead audit and inspection readiness; act as primary quality contact for regulatory inspections and external audits, ensuring timely responses.
• Drive continuous improvement and quality culture through Lean, Six Sigma, and data‑driven decision‑making.
• Build strong cross‑functional partnerships and co‑own manufacturing quality performance, including cost of poor quality (COPQ).
• Lead, develop, and coach the Quality team; establish and monitor key quality metrics and report performance to leadership.

Qualifications & Skills

• Bachelor’s or Master’s degree in Engineering, Life Sciences or a related discipline is required; a Master’s degree is preferred.
• At least 10 years of experience in quality and/or regulatory roles in the medical device industry, including significant experience in manufacturing environments.
• Proven track record as a leader of quality at site or regional level, including direct leadership of a QA/RA team and ownership of QMS processes for a legal manufacturer.
• Experience serving as QA/RA leader for a medical device manufacturer, with authority to approve technical documents and respond to regulators and certifying agencies.
• Significant experience leading regulatory inspections and third‑party audits at production sites, including ISO 13485 and managing responses to findings.
• Fulfilling PRRC requirements according to MDR Article 15 and eligible to be formally designated as PRRC for the legal manufacturer.
• Deep working knowledge of ISO 13485, FDA 21 CFR 820, EU MDR 2017/745 and related medical device regulatory requirements.
• Quality & regulatory leadership in medical device development and manufacturing (preferred: multi‑site operations).
• Strong knowledge of quality systems and quality assurance within a regulated industry (preferably medical devices).
• Experience supporting frequent design transfers and/or post‑market design changes in a high‑change manufacturing environment.
• Experience with automation, AI or digital manufacturing technologies and associated validation and data integrity expectations.
• Regulatory judgment in fast‑moving environments; risk‑based, systems‑level thinking; strong operations partnership and influence skills; data‑driven and digitally fluent quality leadership.
• Fluency in English (written and spoken) is required; additional languages are an advantage.

Permobil is an equal‑opportunity employer committed to diversity and inclusion.

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