Senior Manager Quality Systems

Responsibilitiesarrow_right

* Lead the development, deployment, and continuous improvement of a harmonized global QMS aligned with internal policies, ISO 13485, FDA (21 CFR 820/QMSR), EU MDR, and other applicable regulations.

* Establish standard work, governance, and KPIs to ensure consistent audit execution and audit readiness across all sites.

* Act as global process owner for key quality system elements, including internal audits, external audits, CAPA effectiveness, and risk management.

* Develop and execute a global, internal audit program across all manufacturing sites and functions.

* Ensure readiness for regulatory, customer, and notified body audits; provide leadership during inspections (front room/back room support).

* Identify systemic gaps and drive timely, effective remediation and CAPA closure.

* Develop and implement compliance risk assessment model identifying and prioritizing high risk areas.

* Partner with site Quality, Operations, and Engineering teams to improve product quality and Quality System effectiveness through a robust CAPA process.

* Lead and coach complex investigations into product failures, complaints, and quality signals using structured root cause methodologies.

* Drive global alignment on root cause analysis (RCA) standards, tools, and training.

* Ensure effective integration of risk management activities (e.g., FMEA, hazard analysis) into product and process improvements.

* Partner with Quality leaders across regions and sites to ensure consistent interpretation and application of Corporate QMS requirements.

* Support site leadership in regulatory interactions and compliance strategies.

* Influence cross-functional stakeholders to enable risk-based decision making and a proactive quality culture.

* Build and sustain a culture of compliance, accountability, and continuous improvement.

* Lead training initiatives to strengthen audit readiness, RCA capability, and quality system effectiveness.

* Mentor and develop Quality leaders and key talent across the organization.

Qualificationsarrow_right

* University degree in Engineering, Life Sciences, or related field.

* 10+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry.

* Proven experience in medical device, component manufacturing in multi-site or global manufacturing environments.

* Demonstrated leadership in developing and maintaining ISO 13485, MDSAP, FDA (21 CFR 820/QMSR), EU MDR, ISO 14971, and FDA-compliant Quality Management systems.

* Solid understanding of process validation, design and development, and risk management activities as they relate to medical devices and components for medical devices.

* Effective communicator with strong strategic, analytical, and leadership skills.

* Ability to balance strategic leadership with operational execution.

* Demonstrated experience leading global audit programs and regulatory inspections.

* Proven track record in root cause analysis, CAPA, and product quality improvement.

* Experience managing and developing teams in a global, matrixed organization.

* Business leadership role requires domestic and international travel (up to 40%).