Senior Director, Quality Operations EU

integralife; Freiburg; Vor Ort; CHF 250.000 - 320.000; Vollzeit

Zusammenfassung

Integra LifeSciences seeks a Sr Director of Quality Assurance to lead Quality operations across Le Locle, St. Aubin, and RW sites. You will ensure global QMS compliance, regulatory readiness, and continuous improvement while partnering with site leadership and corporate Quality.

Responsibilities include directing CAPA programs, change control, risk management, and product release decisions, with a focus on patient safety and business continuity.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Minimum 10–12 years of progressive Quality experience in medical devices or regulated healthcare.
• Fluent in English and French.
• Experience leading Quality organizations across multiple sites.

Aufgaben

• Provide leadership to site Quality Assurance teams across Le Locle, St. Aubin, and RW sites.
• Oversee Quality Management System processes including CAPA, nonconformance, complaints, change control, document control, and risk management.
• Lead regulatory inspections, audits, and responses to observations (e.g., FDA 483s).
• Partner with Operations to support production while maintaining quality standards.
• Drive CAPA and continuous improvement with measurable outcomes.
• Mentor Quality leaders and build succession pipelines across sites.

Kenntnisse

Leadership

Quality management

French

English

Regulatory knowledge

Ausbildung

Bachelor’s degree in Engineering or Life Sciences

Master’s degree preferred

Jobbeschreibung

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Sr Director, Quality Assurance provides strategic and operational leadership for Quality Assurance across multiple manufacturing sites within the CSS organization at Integra LifeSciences. Serving as a critical breaker, this role oversees Quality operations for the Le Locle, St. Aubin, and RW sites, ensuring consistent execution of global Quality systems, regulatory compliance, and inspection readiness. Based in Le Locle, Switzerland, the Sr Director partners closely with Site Leadership, Operations, Regulatory, and Corporate Quality to safeguard product quality, patient safety, and business continuity while driving a culture of quality excellence and continuous improvement.

Key Responsibilities

Leadership & Strategy

• Provide leadership and direction to site Quality Assurance teams, including direct oversight of Site Quality leaders.
• Act as the primary Quality liaison and escalation point for the Le Locle, St. Aubin, and RW sites.
• Translate global Quality strategy into effective site-level execution aligned with Integra policies and business objectives.
• Serve as a trusted advisor to site leadership on Quality, risk management, and compliance matters.

Quality Systems Oversight

• Ensure robust and effective implementation of Quality Management System (QMS) processes, including CAPA, nonconformance management, complaints, change control, document control, and risk management.
• Drive harmonization and consistency of Quality processes across sites while accounting for local regulatory and operational needs.
• Oversee management review processes and ensure timely escalation of quality risks and performance trends.

Regulatory & Inspection Readiness

• Ensure ongoing compliance with applicable regulations and standards, including FDA QSR, ISO 13485, EU MDR, and other global regulatory requirements.
• Lead site preparation for regulatory authority inspections, notified body audits, and customer audits; serve as a key inspection leader as needed.
• Review, approve, and ensure timely and effective responses to inspection observations, including FDA 483s, audit findings, and warning letters.

Operational Quality Support

• Partner with Operations and Manufacturing leadership to support production while maintaining compliance and quality standards.
• Provide Quality leadership for deviations, investigations, product impact assessments, and product release decisions.
• Ensure effective change management and risk assessments for process, equipment, and product changes.

CAPA & Continuous Improvement

• Ensure effective root cause analysis, CAPA development, and execution with measurable outcomes.
• Utilize quality metrics, trend analysis, and data-driven insights to proactively identify and mitigate risks.
• Lead and support continuous improvement initiatives to enhance quality, compliance, and efficiency.

People Development

• Develop and mentor Quality leaders and team members across sites, building strong succession pipelines.
• Foster a culture of accountability, transparency, and continuous learning.
• Ensure appropriate training and competency for Quality personnel.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
• Minimum of 10–12 years of progressive Quality experience in the medical device or regulated healthcare industry.
• Demonstrated experience leading Quality organizations in a manufacturing environment.
• Strong working knowledge of global Quality and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR.
• Proven experience leading regulatory inspections and audits.
• Experience managing across multiple sites or complex organizations.
• Fluent in English and French

Preferred Qualifications

• Prior experience in a Director‑level or equivalent senior Quality leadership role.
• Experience serving as a span‑breaker or matrix leader across geographically dispersed sites.
• Strong change leadership and continuous improvement mindset (Lean, Six Sigma, or similar preferred).
• Experience working within a global or multinational organization.