Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.**Responsibilities**:- Lead, Maintenance & Integration of the Quality Management System with all FMCR processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC, MDR 2017/745 & the FDA QSR - 21 CFR Part 820.- Designated Management Representative & Executive Officer for Notified Body & Customer Audits. Management Representative has the responsibility and authority for the following:- Reporting to FMCR management on the performance of the Quality Management System and the need for improvement.- Promotion of awareness of regulatory and customer requirements.- Lead the Quality Assurance Function: Departmental liaison to ensure that products manufactured meet Customer & Regulatory requirements.- Ensuring that new product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, FDA - 21CFR Part 820, MDD 93/42/EEC & MDR 2017/745 when appropriate.- Lead the Customer Complaint investigation process, MDD93/42/EEC & MDR 2017/745 vigilance (Medical Device Reporting requirements and product recalls where necessary.- Lead the Plant Corrective & Preventive action program.- Participation & Maintenance of plant continuous process improvement programs.- Lead the Internal & External Audit Program(s) including quality system & product requirements are included in the plant Training Program(s).- Final Disposition of Non-conforming product including control of re-work & MRB co-ordination.- Training QC employees in procedures and good manufacturing practices.- Support the Data Protection Compliance Officer and champion compliance with data protection legislation. Ensure all processes, systems and employees within area of responsibility are operating compliantly and within the requirements of the GDPR and its principles.- Responsible for certification and validation of controlled areas (Clean rooms). Responsible to maintain the CER areas operative, over the specification's values according to validation and the daily monitoring parameters.- Responsible for metrics tracking and performance related to the quality system as: Company KPIs, scrap rate, scrap cost, PPM, CAPA incidence, QN statistics, etc. Ensuring compliance with budgets and plans.**Qualifications**:- B.S. Degree in Engineering or Master's degree.- Six Sigma Black Belt Certification.- 7 years of Quality, Manufacturing, and/or Product Development, experience.- 5 years minimum of medical device experience.- 5+ years of experience in demonstrated ability to manage, coach and mentor employees.- Excellent English Skills working with teams in the USA.- Experience in a metric driven culture.- Previous experience participating in or leading a Quality audit or section of an audit.- ISO Quality Systems requirements, FDA GMP, and QSR.- Electronic Quality Management System.- Able to review and analyze data and documentation.- Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.- Good reasoning abilities and sound judgment.- Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.- Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.- Accurate and attentive to detail.- Excellent communication and presentation abilities.- Ability to lead and support others.- Ability to read and interpret documents.- Ability to travel as needed (10 - 20%).- Ability to manage customers and have to crucial conversations.Your BenefitsPerformance-related bonus: When you have an impact, you can reap the rewardsDiversity & Inclusion: Enter a diversity-driven world of innovationCar allowance: A monthly allowance to buy/lease, maintain a personal vehicleSustainability / Community service: Making a difference with sustainability, community serviceOccupational safety: Safety as a top priority, in a
