Quality Manager

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.

Some of your Benefits
Cafeteria/ Canteen:
We offer fresh food on-site, both hot and cold.

On-site Medical Service:
Our on-site medical service can handle a variety of medical needs.

Diversity & Inclusion:
We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Health Insurance:
Rely on comprehensive services whenever you need it.

Meal Allowance:
We offer an allowance that makes meals more affordable.

Alajuela

On-Site

Freudenberg Medical srl.

You support our team as

Quality Manager
Responsibilities

• Lead in the development of direct reports to achieve desired results.
• Communicate department goals and objectives, ensuring resources are distributed appropriately.
• Collaboratively create development plans and coach individuals in achieving them.
• 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.
• Report to management on the performance of the Quality Management System.
• Lead / oversee customer / external audit(s).
• Develop relationship with customer quality management.
• Address customer concerns to support strategic approach to the regulations.
• 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.
• 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.

Qualifications

• 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.
• Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.
• Excellent communication and presentation abilities.
• Ability to lead and support others.
• 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.