Working at Freudenberg: We will wow your world!
Lead in the development of direct reports to achieve desired results.
Communicate department goals and objectives, ensuring resources are distributed appropriately.
Maintain regular two-way dialogue with direct reports on work and results.
Collaboratively create development plans and coach individuals in achieving them.
Ensure Quality department’s participation in the Growtth (Lean) program.
Ensure systems and specific product procedures are in place to release product meeting defined requirements.
Responsible for leading the development and management of an effective and compliant quality system by working closely with various cross-functional members.
Ensure quality performance metrics are implemented, monitored and addressed.
Report to management on the performance of the Quality Management System.
Understand and follow all the HSE policies and procedures and ensure the Quality Department be align with these policies and procedures.
Act as the primary contact for customers regarding quality related issues / activities.
Lead / oversee customer / external audit(s).
Develop relationship with customer quality management.
Address customer concerns to support strategic approach to the regulations.
Serve as site Management Representative.
Conduct management review meetings and ensure closures of management review items.
Ensure continuing suitability, adequacy, and effectiveness of Freudenberg Medical Quality Management System.
Oversee CAPA Review Board (CRB) and ensure appropriate actions are taken to resolve QNs in a timely manner.
Responsible for implementing new or revised global quality systems requirements.
Report and resolve customer recalls and field complaints.
Participate in strategic planning activities to ensure that quality related requirements are included in strategic goals and objectives.
Provide quality solutions to support business activities and other assigned task to support the business.
Promote the awareness of quality throughout the business.
Bachelor’s Degree
7 years of Quality, Manufacturing, and/or Product Development, experience.
5 years minimum of medical device experience.
5+ years experience in demonstrated ability to manage, coach and mentor employees.
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%).
Speaking and hearing sufficient for understanding required.
Visual requirements include: close, distance, color, peripheral, and ability to adjust focus.
May involve walking, standing, stooping, bending, balancing, crouching, reaching, grasping, hearing, kneeling, repetitive motions, talking.
Occasionally working near moving mechanical parts.
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.
Freudenberg Medical srl.