Quality in Medical Device jobs

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 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Join our team as a:

Quality Manager

Responsibilities

• Lead the development, implementation and continuous improvement of the site's Quality Management System, ensuring compliance with ISO 13485, FDA QMSR, MDR 2017/745, GMP and other applicable regulatory requirements.
• Act as the site's Management Representative, leading regulatory, customer and Notified Body relationships while ensuring ongoing audit readiness and successful audit outcomes.
• Oversee core quality system processes including CAPA, Change Management, Documentation Control, Internal Audits, Customer Complaints, Post Market Surveillance and Vigilance, driving compliance and continuous improvement.
• Partner with Manufacturing, Engineering, Regulatory Affairs and Operations to embed quality throughout product development, validation, risk management and the full product lifecycle.
• Monitor quality performance metrics, identify improvement opportunities and provide strategic recommendations to senior leadership to enhance product quality and operational performance.
• Lead and develop a high-performing Quality team, fostering a culture of accountability, collaboration, continuous improvement and operational excellence.
• Deputise for the Director of Quality as required and champion Health & Safety, Environmental and Energy Management standards across the site.

Qualifications

• Degree or Master's qualification in Quality Systems, Regulatory Affairs, Biomedical Engineering or a related discipline.
• At least 10 years' experience in Quality within the medical device industry, including a minimum of 3 years leading and developing teams.
• Strong knowledge of ISO 13485, FDA QMSR, MDR 2017/745, GMP and medical device quality system regulations, with experience supporting regulatory and customer audits.
• Proven expertise across key quality processes including CAPA, complaint handling, internal auditing, change management, validation and post-market surveillance.
• Knowledge of ISO 14001, ISO 45001 and ISO 50001, with a commitment to promoting safe, sustainable and compliant operations.
• Strong leadership, communication and stakeholder management skills, with the ability to influence and collaborate across cross-functional teams.
• Experience driving Lean and continuous improvement initiatives within a regulated manufacturing environment.
• Lead Auditor qualification is desirable, while knowledge of microbiology would be an advantage.

Some of your Benefits

Company Pension

Health Insurance

Rely on comprehensive services whenever you need it.

Performance Related Bonus

When you have an impact, you can reap the rewards.

Personal Development

We offer a variety of trainings to ensure you can develop in your career.

Flexible Work Models

We allow for flexible work models to ensure both professional and personal success.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.