Senior Manager Quality Systems

Freudenberg Group•Beverly, MA

About The Position

Working at Freudenberg: We will wow your world! This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Requirements

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%).

Responsibilities

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.